Drug product
PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821.
D-991-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-991-2014
Official wording
Reason: Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: PHENobarbital, Tablet, 64.8 mg, NDC 00603516721, Pedigree: AD73518_7, EXP: 5/31/2014.
Code information: PHENobarbital, Tablet, 97.2 mg has the following codes: Pedigree: AD73518_10, EXP: 5/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled