Drug Enforcement D-972-2014

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.

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Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.
Product quantity
300 Tablets
Reason for recall
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.
Recall initiation reason
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Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-972-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
CYCLOBENZAPRINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD46265_4, 5/15/2014; Pedigree: AD73525_7, 5/30/2014.
More code info
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