US Drug Recall Register
Class III · Low risk Terminated Initiated Aug 19, 2014 (12 years ago)

Nicotine Polacrilex Lozenge

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

What was recalled

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.

Recalling firm
Perrigo Holland Inc
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1558-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other East recalls

See all
Class II · Moderate risk Ongoing

Diovan

Reason Failed Dissolution Specifications

Novartis Pharmaceuticals Corporation NDC 0078-0359-34 D-0746-2026
Class II · Moderate risk Ongoing

Clindamycin Palmitate Hydrochloride for Oral Solution

Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Heritage Pharmaceuticals Inc NDC 23155-603-51 D-0768-2026
Class II · Moderate risk Ongoing

Dicyclomine Hydrochloride Capsules

Reason shortfill; reports of empty capsules.

Aurobindo Pharma USA Inc NDC 59651-719-99 D-0733-2026
Class II · Moderate risk Ongoing

Rising

Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Rising Pharma Holding, Inc. NDC 64980-504-48 D-0724-2026
Class I · High risk Ongoing

Cetirizine Hydrochloride Tablets USP 5 mg

Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

JB Chemicals and Pharmaceuticals Ltd NDC 16571-401-10 D-0732-2026