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

caribpr — Wed, 06 Feb 2013 04:16:25 +0000

– 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 Trinidad & Tobago

– 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 Trinidad & Tobago 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 Trinidad & Tobago 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

Novartis Corporation

+1 212 830 2465 (direct)

+1 862 579 8456 (mobile)

julie.masow@novartis.com

Pamela McKinlay

Novartis Consumer Health, Inc.

+1 973 503 7337(direct)

+1 862 221 0151(mobile)

pamela.mckinlay@novartis.com

e-mail: us.mediarelations@novartis.com

Milicent Brooks

Novartis Consumer Health, Inc.

+1 973 503 7483(direct)

+1 973 479 2078 (mobile)

milicent.brooks@novartis.com

Francisco Ericastilla

Novartis Farmaceutica, S.A. (AC)

+502 242 28438 (direct)

+502 571 09426 (mobile)

francisco.ericastilla@novartis.com

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Theraflu Warming Relief® Syrups

PRODUCT	Item UPC NUMBER	NDC NUMBER	Case UCC NUMBER	Size	LOT	EXPIRY DATE
Theraflu ® 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® 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® 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® 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® 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® Warming Relief Sinus and Cold, 8.3 oz.	300436407085	67640708	10300436407082	8.3 oz	10095358	04/30/2013
Theraflu® Warming Relief Sinus and Cold, 8.3 oz.	300436407085	67640708	10300436407082	8.3 oz	10104966	07/31/2013

Triaminic® Syrups

PRODUCT	Item UPC NUMBER	NDC NUMBER	Case UCC NUMBER	Size	LOT	EXPIRY DATE
Triaminic® 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® 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® 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® 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® 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® 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® 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® 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® 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® 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® 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® 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® 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® 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® 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

CaribPR Wire » Jack & Jill® brand pediatric syrups and Buckley’s® Complete Liquid

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