Recalls / Class III
Class IIID-1244-2014
Product
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
- Affected lot / code info
- 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).
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
- 12,162 Pallets
- 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-1244-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.