Novartis Pharma Logistics, Inc. voluntarily recalling in Barbados select lots of certain over-the-counter products due to bottle closure defect
06 February 2013
- 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 Barbados 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 in the US, 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 Barbados 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)
Pamela McKinlay Novartis Consumer Health, Inc. +1 973 503 7337(direct) +1 862 221 0151(mobile)
e-mail: [email protected] |
Milicent Brooks Novartis Consumer Health, Inc. +1 973 503 7483(direct) +1 973 479 2078 (mobile)
Francisco Ericastilla Novartis Farmaceutica, S.A. (AC) +502 242 28438 (direct) +502 571 09426 (mobile)
|
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 ® 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 |
|
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 |
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