Novartis Pharma Logistics, Inc. voluntarily recalling in Curacao 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 Curacao
– 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, 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 Curacao 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 US prior to the voluntary suspension of operations in December 2011. In addition to production at the US manufacturing 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 Curacao Public Health Department.
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.
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Novartis Media Relations
Julie Masow Milicent Brooks
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Pamela McKinlay Francisco Ericastilla
Novartis Consumer Health, Inc. Novartis Farmaceutica, S.A. (AC)
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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 10300436216080 10095906 01/31/2013
------------------------------------- ------------ -------- -------------- -------- ----------
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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