Drug product
CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.
D-972-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-972-2014
Official wording
Reason: 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.
Code information: CYCLOBENZAPRINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD46265_4, 5/15/2014; Pedigree: AD73525_7, 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled