Posts Tagged ‘Novartis Pharma Logistics’

Novartis Pharma Logistics, Inc. voluntarily recalling in Jamaica select lots of certain over-the-counter products due to bottle closure defect

– Voluntary recall of certain lots of Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley’s® Complete Liquids, issued to consumers, retail customers and wholesalers in Jamaica

– Consumers who may have the product(s) being recalled are asked to return the affected products and receive a full refund

– The products being recalled were produced at a Novartis Consumer Health manufacturing facility in the United States prior to the voluntary suspension of operations in December 2011, and at a third-party manufacturing site in Canada using the same bottle and cap components

PANAMA CITY, Fla., Feb. 5, 2013 /PRNewswire/ — Novartis Pharma Logistics, Inc. announced today that it is voluntarily recalling certain lots of Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley’s® Complete Liquids. Novartis Pharma Logistics has decided to issue a voluntary recall to consumers, retail customers and wholesalers in Jamaica because the child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place. The affected bottle sizes are included at the end of this release.

Novartis Pharma Logistics has not received any adverse events due to the tamper evident seal causing a failure of the child resistant cap. Novartis Consumer Health, Inc.  in the United States received four adverse events for Triaminic® Syrups related to this issue.

Triaminic® Syrups, Theraflu Warming Relief® Syrups, Jack & Jill® brand pediatric syrups and Buckley’s® Complete Liquids continue to be safe and effective when used as directed on the package label.

The products being recalled were produced at a Novartis Consumer Health manufacturing facility in the US prior to the voluntary suspension of operations in December 2011. In addition to production at the US site, Buckley’s Complete® was also produced until January 2013 at a third-party manufacturing site in Canada. A consumer complaint in the US in late November 2012 triggered an internal investigation by Novartis Consumer Health that determined a voluntary recall was in the best interest of consumers.

Action to be taken by consumers

Novartis Pharma Logistics advises consumers who believe they have product included in this recall to discontinue use and return the recalled product to the store or pharmacy where it was purchased for a full refund.  Only recalled product in the original bottle will be eligible for a refund. Consumers may contact the Novartis Consumer Relationship Center at 877-769-8420 (available Monday-Saturday 8 a.m. to 6 p.m. Eastern Time) for more detailed information about the recall, including which products are impacted, and for information on how to return the affected products and receive a full refund.

Action to be taken by retailers and wholesalers

Retailers and wholesalers should stop distribution and return the affected lots using the Novartis Product Return information that is being provided to them. Retailers that receive product returns from consumers will be reimbursed by Novartis Pharma Logistics.

This recall is being conducted with the full knowledge of the Jamaica Ministry of Health.

Disclaimer

The foregoing release contains forward-looking statements including express or implied discussions regarding potential future revenues from Novartis OTC products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Novartis OTC products will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding such products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

Novartis Media Relations

Julie Masow                            Milicent Brooks
Novartis Corporation                   Novartis Consumer Health, Inc.
+1 212 830 2465 (direct)                                                   +1 973 503 7483(direct)
+1 862 579 8456 (mobile)                                                  +1 973 479 2078 (mobile)
[email protected]               [email protected]
Pamela McKinlay                        Francisco Ericastilla
Novartis Consumer Health, Inc.         Novartis Farmaceutica, S.A. (AC)
+1 973 503 7337(direct)                                                    +502 242 28438 (direct)
+1 862 221 0151(mobile)                                                    +502 571 09426 (mobile)
[email protected]           [email protected]
e-mail: [email protected]

For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis.
For questions about the site or required registration, please contact: [email protected].

Theraflu Warming Relief® Syrups

                  PRODUCT                              Item UPC NUMBER                    NDC NUMBER                       Case UCC NUMBER                       Size                       LOT                        EXPIRY DATE
                  -------                              ---------------                    ----------                       ---------------                       ----                       ---                        -----------
Theraflu (R) Warming Relief Flu and Sore
 Throat, 8.3 oz.                                                    300436265081                    43626508                             10300436265088  8.3 oz                                     10108935                     03/31/2013
----------------------------------------                            ------------                    --------                             --------------  ------                                     --------                     ----------
                                  10096570                            05/31/2013
                                  --------                            ----------
                                  10121298                            05/31/2013
                                  --------                            ----------
                                  10123035                            05/31/2013
                                  --------                            ----------
                                  10106483                            06/30/2013
                                  --------                            ----------
                                  10126716                            07/31/2013
                                  --------                            ----------
Theraflu(R) Daytime Warming Relief Severe
 Cold and Cough, 8.3 oz.                                            300430461083                    43046108                             10300430461080  8.3 oz                                     10096571                     04/30/2013
-----------------------------------------                           ------------                    --------                             --------------  ------                                     --------                     ----------
                                  10117845                            04/30/2013
                                  --------                            ----------
                                  10102070                            06/30/2013
                                  --------                            ----------
                                  10118134                            06/30/2013
                                  --------                            ----------
                                  10118135                            08/31/2013
                                  --------                            ----------
                                  10126586                            08/31/2013
                                  --------                            ----------
                                  10126729                            10/31/2013
                                  --------                            ----------
Theraflu(R) Daytime/Nighttime Severe Cold
 & Cough Value Pack                                                 300436412164                    67641216                             10300436412161                                             10120065                     03/01/2013
-----------------------------------------                           ------------                    --------                             --------------                                             --------                     ----------
10116591A                                                             03/13/2013
---------                                                             ----------
                                  10116591                            03/31/2013
                                  --------                            ----------
                                  10116593                            03/31/2013
                                  --------                            ----------
                                  10106487                            05/31/2013
                                  --------                            ----------
                                  10108285                            05/31/2013
                                  --------                            ----------
                                  10116594                            06/30/2013
                                  --------                            ----------
                                  10116597                            06/30/2013
                                  --------                            ----------
                                  10116598                            06/30/2013
                                  --------                            ----------
                                  10116600                            06/30/2013
                                  --------                            ----------
                                  10116601                            08/31/2013
                                  --------                            ----------
                                  10116602                            08/31/2013
                                  --------                            ----------
Theraflu(R) Nighttime Warming Relief
 Severe Cold and Cough, 8.3 oz.                                     300430460086                    43046008                             10300430460083  8.3 oz                                     10104954                     04/30/2013
------------------------------------                                ------------                    --------                             --------------  ------                                     --------                     ----------
                                  10104955                            05/31/2013
                                  --------                            ----------
                                  10107018                            05/31/2013
                                  --------                            ----------
                                  10118113                            05/31/2013
                                  --------                            ----------
                                  10123039                            05/31/2013
                                  --------                            ----------
                                  10104956                            07/31/2013
                                  --------                            ----------
                                  10126861                            08/31/2013
                                  --------                            ----------
Theraflu(R) Warming Relief Cold and Chest
 Congestion, 8.3 oz.                                                300436296085                    43629608                             10300436296082  8.3 oz                                     10106482                     01/31/2013
-----------------------------------------                           ------------                    --------                             --------------  ------                                     --------                     ----------
                                  10102071                            07/31/2013
                                  --------                            ----------
                                  10113497                            07/31/2013
                                  --------                            ----------
                                  10122891                            08/31/2013
                                  --------                            ----------
                                  10123274                            08/31/2013
                                  --------                            ----------
                                  10126440                            09/30/2013
                                  --------                            ----------
                                  10128457                            11/30/2013
                                  --------                            ----------
Theraflu(R) Warming Relief Sinus and Cold,
 8.3 oz.                                                            300436407085                    67640708                             10300436407082  8.3 oz                                     10095358                     04/30/2013
------------------------------------------                          ------------                    --------                             --------------  ------                                     --------                     ----------
                                  10104966                            07/31/2013
                                  --------                            ----------

Triaminic® Syrups

                  PRODUCT                       Item UPC
                                                 NUMBER       NDC NUMBER    Case UCC NUMBER         Size                    LOT                      EXPIRY DATE
                  -------                         --------    ----------    ---------------         ----                    ---                      -----------
Triaminic(R) Cold and Allergy, 4 oz.          300436346049        67634604    10300436346046  4 oz                                10092519                     01/31/2013
------------------------------------          ------------        --------    --------------  ----                                --------                     ----------
                                  10096507                        02/28/2013
                                  --------                        ----------
                                  10092518                        04/30/2013
                                  --------                        ----------
                                  10102344                        05/31/2013
                                  --------                        ----------
                                  10102052                     06/30/2013
                                  --------                     ----------
                                  10098505                     07/31/2013
                                  --------                     ----------
                                  10106511                     11/30/2013
                                  --------                     ----------
                                  10099191                     12/31/2013
                                  --------                     ----------
                                  10122929                     02/28/2014
                                  --------                     ----------
                                  10125956                     05/31/2014
                                  --------                     ----------
Triaminic(R) Cough and Sore Throat, 4 oz.     300436348043        67634804    10300436348040  4 oz                                10104678                     02/28/2013
-----------------------------------------     ------------        --------    --------------  ----                                --------                     ----------
                                  10107025                     02/28/2013
                                  --------                     ----------
                                  10107026                     05/31/2013
                                  --------                     ----------
                                  10117681                     06/30/2013
                                  --------                     ----------
                                  10118052                     08/31/2013
                                  --------                     ----------
                                  10126850                     09/30/2013
                                  --------                     ----------
Triaminic(R) Day Time Cold and Cough, 4
 oz.                                          300436345042        67634504    10300436345049  4 oz                                10092520                     01/31/2013
---------------------------------------       ------------        --------    --------------  ----                                --------                     ----------
                                  10095545                     01/31/2013
                                  --------                     ----------
                                  10117453                     02/28/2013
                                  --------                     ----------
                                  10097308                     03/31/2013
                                  --------                     ----------
                                  10095904                     04/30/2013
                                  --------                     ----------
                                  10099699                     05/31/2013
                                  --------                     ----------
                                  10102053                     06/30/2013
                                  --------                     ----------
                                  10103616                     07/31/2013
                                  --------                     ----------
                                  10107024                     08/31/2013
                                  --------                     ----------
                                  10103617                     09/30/2013
                                  --------                     ----------
                                  10114266                     10/31/2013
                                  --------                     ----------
                                  10116660                     11/30/2013
                                  --------                     ----------
                                  10116869                     12/31/2013
                                  --------                     ----------
                                  10116870                     02/28/2014
                                  --------                     ----------
                                  10126445                     03/31/2014
                                  --------                     ----------
Triaminic(R) Daytime/Nighttime Cold &
 Cough Club Pack                              300436417121             N/A    10300436417135                                      10095327                     01/31/2013
-------------------------------------         ------------             ---    --------------                                      --------                     ----------
                                  10095907                     01/31/2013
                                  --------                     ----------
                                  10097748                     01/31/2013
                                  --------                     ----------
                                  10095298                     04/30/2013
                                  --------                     ----------
                                  10117817                     12/31/2013
                                  --------                     ----------
                                  10117818                     03/31/2014
                                  --------                     ----------
                                  10117819                     03/31/2014
                                  --------                     ----------
Triaminic(R) Daytime/Nighttime Cold &
 Cough Combo Pack                             300436216083        67621608                                                        10095906                     01/31/2013
                                                                              10300436216080
---
                                  10099216                     02/28/2013
                                  --------                     ----------
                                  10100792                     04/30/2013
                                  --------                     ----------
                                  10100793                     04/30/2013
                                  --------                     ----------
                                  10101494                     05/31/2013
                                  --------                     ----------
                                  10101495                     05/31/2013
                                  --------                     ----------
                                  10106846                     05/31/2013
                                  --------                     ----------
                                  10104675                     06/30/2013
                                  --------                     ----------
                                  10106086                     06/30/2013
                                  --------                     ----------
                                  10106088                     07/31/2013
                                  --------                     ----------
                                  10106284                     07/31/2013
                                  --------                     ----------
                                  10106848                     08/31/2013
                                  --------                     ----------
                                  10110968                     08/31/2013
                                  --------                     ----------
                                  10113146                     09/30/2013
                                  --------                     ----------
                                  10113147                     11/30/2013
                                  --------                     ----------
                                  10115037                     11/30/2013
                                  --------                     ----------
                                  10116592                     12/31/2013
                                  --------                     ----------

Triaminic® Syrups (Cont.)

                  PRODUCT                       Item UPC
                                                 NUMBER             NDC NUMBER          Case UCC NUMBER           Size                     LOT                      EXPIRY DATE
                  -------                         --------          ----------          ---------------           ----                     ---                      -----------
Triaminic(R) Daytime/Nighttime Cold &
 Cough Combo Pack (Cont.)                     300436216083                    67621608    10300436216080                                         10116595                     12/31/2013
-------------------------------------         ------------                    --------    --------------                                         --------                     ----------
10116596                                        12/31/2013
--------                                        ----------
10116599                                        03/31/2014
--------                                        ----------
10123383                                        03/31/2014
--------                                        ----------
10123388                                        03/31/2014
--------                                        ----------
Triaminic(R) Dye-free Long Acting Cough,
 4 oz.                                        300436350046                    67635004    10300436350043  4 oz                                   10081942                     04/30/2013
----------------------------------------      ------------                    --------    --------------  ----                                   --------                     ----------
10082283                                        04/30/2013
--------                                        ----------
10081940                                        06/30/2013
--------                                        ----------
10097082                                        07/31/2013
--------                                        ----------
10082927                                        09/30/2013
--------                                        ----------
10095893                                        10/31/2013
--------                                        ----------
10095894                                        10/31/2013
--------                                        ----------
10102049                                        11/30/2013
--------                                        ----------
10102048                                        12/31/2013
--------                                        ----------
10106251                                        12/31/2013
--------                                        ----------
10102051                                        01/31/2014
--------                                        ----------
10107021                                        02/28/2014
--------                                        ----------
10107022                                        05/31/2014
--------                                        ----------
10118430                                        07/31/2014
--------                                        ----------
10121529                                        08/31/2014
--------                                        ----------
10129170                                        11/30/2014
--------                                        ----------
Triaminic(R) Fever Reducer Pain Reliever
 Bubblegum, 4 oz.                             300436432049                    67643204    10300436432046  4 oz                                   10093941                     01/31/2013
----------------------------------------      ------------                    --------    --------------  ----                                   --------                     ----------
10102270                                        02/28/2013
--------                                        ----------
10112423                                        03/31/2013
--------                                        ----------
10106334                                        05/31/2013
--------                                        ----------
10116891                                        08/31/2013
--------                                        ----------
Triaminic(R) Fever Reducer Pain Reliever
 Grape, 4 oz.                                 300436431042                    67643104    10300436431049  4 oz                                   10092719                     01/31/2013
----------------------------------------      ------------                    --------    --------------  ----                                   --------                     ----------
10108530                                        02/28/2013
--------                                        ----------
10112422                                        03/31/2013
--------                                        ----------
10106335                                        05/31/2013
--------                                        ----------
10093939                                        08/31/2013
--------                                        ----------
10126470                                        10/31/2013
--------                                        ----------
10127629                                        11/30/2013
--------                                        ----------
10130550                                        11/30/2013
--------                                        ----------
Triaminic(R) Fever Reducer Pain Reliever
 Infant Bubblegum, 2 oz.                      300676441597                    67644159    10300676441594  2 oz                                   10115515                     05/31/2013
----------------------------------------      ------------                    --------    --------------  ----                                   --------                     ----------
10115516                                        05/31/2013
--------                                        ----------
10115520                                        05/31/2013
--------                                        ----------
10115521                                        05/31/2013
--------                                        ----------
10119567                                        09/30/2013
--------                                        ----------
10128589                                        11/30/2013
--------                                        ----------
Triaminic(R) Fever Reducer Pain Reliever
 Infant Grape, 2 oz.                          300676440590                    67644059    10300676440597  2 oz                                   10115517                     05/31/2013
----------------------------------------      ------------                    --------    --------------  ----                                   --------                     ----------
10115518                                        05/31/2013
--------                                        ----------
10115519                                        05/31/2013
--------                                        ----------
10115522                                        05/31/2013
--------                                        ----------
10123421                                        09/30/2013
--------                                        ----------
10128599                                        11/30/2013
--------                                        ----------
10130570                                        11/30/2013
--------                                        ----------
Triaminic(R) Multi Symptom Fever, 3.4 oz.     300676394343                    67639434    10300676394340  3.4 oz                                 10116856                     06/30/2013
-----------------------------------------     ------------                    --------    --------------  ------                                 --------                     ----------
10116857                                        06/30/2013
--------                                        ----------
10126948                                        09/30/2013
--------                                        ----------

Triaminic® Syrups (Cont.)

           PRODUCT Item UPC NUMBER           NDC NUMBER         Case UCC NUMBER                     Size LOT          EXPIRY DATE
           ------- ---------------           ----------         ---------------                     ---- ---          -----------
Triaminic(R)
 Multi
 Symptom
 Fever, 4 oz.                   300436394040           67639404               10300436394047 4 oz            10110769           02/28/2013
-------------                   ------------           --------               -------------- ----            --------           ----------
10095563                          03/31/2013
--------                          ----------
10102058                          03/31/2013
--------                          ----------
10102271                          05/31/2013
--------                          ----------
10116866                          06/30/2013
--------                          ----------
10116867                          06/30/2013
--------                          ----------
10116868                          06/30/2013
--------                          ----------
10121656                          08/31/2013
--------                          ----------
10126740                          10/31/2013
--------                          ----------
10128836                          11/30/2013
--------                          ----------
Triaminic(R)
 Night Time
 Cold and
 Cough, 3.4
 oz.                            300436344342           67634434               10300436344349 3.4 oz          10097303           03/31/2013
------------                    ------------           --------               -------------- ------          --------           ----------
10097552                          04/30/2013
--------                          ----------
10097554                          06/30/2013
--------                          ----------
10108819                          08/31/2013
--------                          ----------
10114273                          12/31/2013
--------                          ----------
10126947                          03/31/2014
--------                          ----------
Triaminic(R)
 Night Time
 Cold and
 Cough, 4 oz.                   300436344045           67634404               10300436344042 4 oz            10094309           01/31/2013
-------------                   ------------           --------               -------------- ----            --------           ----------
10095895                          03/31/2013
--------                          ----------
10097312                          04/30/2013
--------                          ----------
10097313                          04/30/2013
--------                          ----------
10104673                          05/31/2013
--------                          ----------
10102054                          06/30/2013
--------                          ----------
10106850                          07/31/2013
--------                          ----------
10108823                          08/31/2013
--------                          ----------
10111184                          08/31/2013
--------                          ----------
10101373                          11/30/2013
--------                          ----------
10114269                          12/31/2013
--------                          ----------
10118449                          12/31/2013
--------                          ----------
10121342A                         12/31/2013
---------                         ----------
10121812                          02/28/2014
--------                          ----------
10106851                          03/31/2014
--------                          ----------
10126742                          05/31/2014
--------                          ----------

Triaminic® Syrups (Cont.)

                                                  PRODUCT Item UPC NUMBER       DIN    SCC                   Size    LOT
                                                  ------- ---------------       ---    ---                   ----    ---
Triaminic Chest & Nasal Congestion - Tropical Fruit                  58478 10163 7 2278308  20058478101631 100 mL All
---------------------------------------------------                  ------------- -------  -------------- ------ ---
Triaminic Cold & Cough- Cherry                                       58478 47100 6 2243739  20058478471000 100 mL All
------------------------------                                       ------------- -------  -------------- ------ ---
Triaminic Cold & Nighttime Cough - Grape                              58478 47102 0 896179  20058478471024 100 mL All
----------------------------------------                              ------------- ------  -------------- ------ ---
Triaminic Cough & Sore Throat - Grape                                58478 47108 2 2130564  20058478471086 100 mL All
-------------------------------------                                ------------- -------  -------------- ------ ---
Triaminic Long Acting Cough - Berry Punch                            58478 10168 2 2277972 200058478101686 100 mL All
-----------------------------------------                            ------------- ------- --------------- ------ ---
Triaminic Total Cold, Cough & Fever - Bubble Gum                      58478 47104 4 2239666 20058478471048 100 mL All
------------------------------------------------                      ------------- ------- -------------- ------ ---

Buckley´s® Complete Liquids

                                                    PRODUCT Item UPC NUMBER       DIN     SCC                  Size    LOT
                                                    ------- ---------------       ---     ---                  ----    ---
Buckley's Complete with Mucus Relief Extra Strength                     58478 10792 9 2357232 20058478107923 150 mL All
---------------------------------------------------                     ------------- ------- -------------- ------ ---
Buckley's Complete with Mucus Relief Extra Strength                     58478 10776 9 2357232 20058478107763 250 mL All
---------------------------------------------------                     ------------- ------- -------------- ------ ---
Buckley's Complete PM - Nighttime                                       58478 10777 6 2356457 20058478107770 150 mL All
---------------------------------                                       ------------- ------- -------------- ------ ---
Buckley's Complete                                                      58478 10295 5 2279703 20058478102959 250 mL All
------------------                                                      ------------- ------- -------------- ------ ---
Buckley's Complete                                                      58478 10295 5 2279703 20058478102959 250 mL All
------------------                                                      ------------- ------- -------------- ------ ---
Buckley's Complete                                                      58478 10064 7 2279703 20058478100641 150 mL All
------------------                                                      ------------- ------- -------------- ------ ---
Buckley's Complete                                                      58478 10064 7 2279703 20058478100641 150 mL All
------------------                                                      ------------- ------- -------------- ------ ---

Jack & Jill® Pediatric Syrups

                                                   PRODUCT Item UPC NUMBER       DIN     SCC                  Size    LOT
                                                   ------- ---------------       ---     ---                  ----    ---
Jack & Jill Bedtime - Grape                                            65515 00010 5 2241167 10065515000102 100 mL All
---------------------------                                            ------------- ------- -------------- ------ ---
Jack & Jill Cough & Cold – Cherry                                      65515 00021 1 2242588 10065515000218 100 mL All
---------------------------------                                      ------------- ------- -------------- ------ ---
Jack & Jill Children's Formula Cough Liquid - Cherry                   65515 00019 8  823023 10065515000195 100 mL All
----------------------------------------------------                   -------------  ------ -------------- ------ ---
Jack & Jill Cough Syrup - Raspberry                                    65515 00008 2  622036 10065515000089 100 mL All
-----------------------------------                                    -------------  ------ -------------- ------ ---
Jack & Jill Expectorant - Raspberry                                    58478 10798 1 2350084 20058478107985 100 mL All
-----------------------------------                                    ------------- ------- -------------- ------ ---
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