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FDAFDA · Food and drugs·Recall number D-972-2014

CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.

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: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014.

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
CYCLOBENZAPRINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD46265_4, 5/15/2014; Pedigree: AD73525_7, 5/30/2014.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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