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FDAFDA · Food and drugs·Recall number D-925-2014

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

Published January 29, 2014 · Recall initiated: July 2, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Aidapak Services, LLC
Distributor
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Lot
NICOTINE POLACRILEX, GUM, 2 mg has the following codes: Pedigree: AD33897_28, EXP: 2/28/2014; Pedigree: W003100, EXP: 6/13/2014.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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