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.
Drug Recall
Official source record
- Recall number
- D-1558-2014
- Event ID
- 69048
- Classification
- Class III
- Status
- Terminated
- Recalling company
- Perrigo Holland Inc
- Reason for recall
- Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
- Report date
- September 3, 2014
- Recall initiation date
- August 19, 2014
- Termination date
- January 13, 2015
- Distribution pattern
- U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.
Drug product identifiers
- Manufacturer
- American Sales Company; CVS Pharmacy; Wal-Mart Stores Inc; Walgreen Company
- Brand names
- CAREONE NICOTINE; EQUATE NICOTINE; NICOTINE; NICOTINE MINI
- Generic name
- NICOTINE POLACRILEX
- Substance name
- NICOTINE
- Product NDCs
- 0363-0734; 41520-734; 49035-734; 59779-734
- Package NDCs
- 0363-0374-04; 0363-0734-02; 0363-0734-03; 0363-0734-04; 0363-0734-05; 11673-734-02; 11822-0734-2; 11822-0734-3; 30142-734-02; 36800-734-60; 41520-734-01; 41520-734-02; 41520-734-03; 49035-734-01; 49035-734-03; 49035-734-04; 59779-734-01; 59779-734-02; 59779-734-04; 59779-734-52; 59779-734-60
- Route
- ORAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
