PlainRecalls
FDA Drug Moderate Class II Terminated

NICOTINE POLACRILEX, GUM, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536302923.

Reported: January 29, 2014 Initiated: July 2, 2013 #D-925-2014

Product Description

NICOTINE POLACRILEX, GUM, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536302923.

Reason for Recall

Labeling: Label Mixup:NICOTINE POLACRILEX, GUM, 2 mg may have potentially been mislabeled as one of the following drugs: FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: AD33897_22, EXP: 5/9/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: W003099, EXP: 6/13/2014.

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
1210 Pieces
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
NICOTINE POLACRILEX, GUM, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536302923.. Recalled by Aidapak Services, LLC. Units affected: 1210 Pieces.
Why was this product recalled?
Labeling: Label Mixup:NICOTINE POLACRILEX, GUM, 2 mg may have potentially been mislabeled as one of the following drugs: FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: AD33897_22, EXP: 5/9/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: W003099, EXP: 6/13/2014.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-925-2014.