FDAClass IIIApril 30, 2014

Nicorette Lozenge recall: Superpotent

Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK…

Why was Nicorette Lozenge 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?

Lot #12K16W (exp 5/14), 12K27N (exp 6/14), 12K27W (exp 6/14), 12K29N (exp 6/14), 13K20W (exp 6/15), 13K20W1 (exp 6/15) & 13K25N (exp 6/15).

Product
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK…
Recalling firm
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Quantity
12,162 Pallets
Distribution
U.S. Nationwide
Recall date
April 30, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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