Recalls / Class II
Class IID-972-2014
Product
CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.
- Affected lot / code info
- CYCLOBENZAPRINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD46265_4, 5/15/2014; Pedigree: AD73525_7, 5/30/2014.
Why it was recalled
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.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 300 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-972-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.