FDA recall D-1247-2014

Product

Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.

Reason for recall

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2014-02-20

Report date

2014-04-30

Termination date

2017-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aiken, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1247-2014