Class III · Low risk
Nicotine Transdermal System Patch
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Affected NDCs
0363-0374-04
0363-0734-02
11673-0734-02
11822-0734-02
11822-0734-03
30142-0734-02
36800-0734-60
41520-0734-02
41520-0734-03
49035-0734-01
49035-0734-03
49035-0734-04
+1 more
Compare with the code on your package — it is the most precise check available.
Drug: Nicotine
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| migraine relief Acetaminophen, Aspirin, Caffeine NDC 00363-0374 |
ACETAMINOPHEN 250 mg/1; ASPIRIN 250 mg/1; CAFFEINE 65 mg/1 | Tablet, Film Coated Oral |
Walgreen Company | OTC |
| Topcare Nicotine Nicotine Polacrilex NDC 36800-0734 |
NICOTINE 2 mg/1 | Lozenge Oral |
Topco Associates LLC | OTC |
| CareOne Nicotine Nicotine Polacrilex NDC 41520-0734 |
NICOTINE 2 mg/1 | Lozenge Oral |
American Sales Company | OTC |
| Equate Nicotine Nicotine Polacrilex NDC 49035-0734 |
NICOTINE 2 mg/1 | Lozenge Oral |
Wal-Mart Stores Inc | OTC |
| Nicotine Nicotine Polacrilex NDC 59779-0734 |
NICOTINE 2 mg/1 | Lozenge Oral |
CVS Pharmacy | OTC |
- Recalling firm
- Perrigo Holland Inc
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1558-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nicotine recalls
See all
Class III · Low risk
Nicotine Gum
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Class III · Low risk
Nicorette Lozenge and NicoDerm CQ
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Other dissolution failure recalls from 2014
All dissolution failure recalls
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk
Mercaptopurine Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 12 month stability time point
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specification; at the 6-month stability time point
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