Nicorette recall: Superpotent
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
Why was Nicorette recalled?
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(20 ct) Lot #13444 (exp 05/14), 13486 (exp 06/14), 13547 (exp 06/14), 13619 (exp 06/14), 13675 (exp 07/14), 13833 (exp 11/14), 13921 (exp 11/14), 14008 (exp 1/15), 14150 (exp 4/15), 14195 (exp 4/15), 14260 (exp 7/15), 14286 (exp 7/15), 14379 (exp 9/15), 14428 (exp 9/15), 14463 (exp9/15) & 14507 (exp 10/15); (27 ct) Lot: 14190 (exp 5/15), 14383 (exp 9/15); (81 ct) Lot # 13374 (exp 4/14), 13392 (exp 4/14), 13445 (exp 5/14), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct) Lot #12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15).
- Product
- Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
- Recalling firm
- GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Quantity
- 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials
- Distribution
- U.S. Nationwide
- Recall date
- April 30, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)