Recalls / Class III
Class IIID-1243-2014
Product
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
- Affected lot / code info
- 81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15).
Why it was recalled
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Recalling firm
- Firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 65 Windham Blvd, N/A, Aiken, South Carolina 29805-9384
Distribution
- Quantity
- 146,424 81 Ct. Vials, 105,091 189 Ct Vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-02-20
- FDA classified
- 2014-04-18
- Posted by FDA
- 2014-04-30
- Terminated
- 2017-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1243-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.