August 2014 FDA Recall Nicotine Mini by Perrigo Holland Inc
D-1558-2014 - Failed Dissolution Specifications and Failed Tablet Specifications
This Class III drug recall was voluntarily initiated by Perrigo Holland Inc on August 19, 2014 for the product Nicotine Mini. The FDA reported the reason for recall as failed dissolution specifications and failed tablet specifications. The product was distributed in U.S. Distribution: OH, RI, OR, PA, MN, IL, AR. and the recall is currently terminated.
Recall Number: D-1558-2014
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
08-19-2014
09-03-2014
366,936 Tubes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Perrigo Holland Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
01-13-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.
Batch or Lot Expiration Information
Lot# Cartons of 27 ct Tubes:
Lot# : 2MV1074, Expiry: 09/14
Lot# : 2MV1124, Expiry: 09/14
Lot# : 2MV1142, Expiry: 09/14
Lot# : 2MV1143, Expiry: 09/14
Lot# : 3AV0528, Expiry: 09/14
Lot# : 3FV0575, Expiry: 09/14
Lot# : 3FV0535, Expiry: 03/15
Lot# : 3FV0537, Expiry: 03/15
Lot# : 3FV0576, Expiry: 03/15
Lot# : 3FV0579, Expiry: 03/15
Lot# : 3FV0615, Expiry: 03/15
Lot# : 3FV0739, Expiry: 03/15
Lot# : 3FV0742, Expiry: 03/15
Lot# : 3GV0713, Expiry: 03/15
Lot# : 3GV0715, Expiry: 03/15
Lot# : 3FV0421, Expiry: 03/15
Lot# : 3FV0422, Expiry: 03/15
Lot# : 3FV0423, Expiry: 03/15
Lot# : 3FV0740, Expiry: 03/15. 20 Ct Stretchcard:
Lot# : 3FV0520, Expiry: 03/15.
