Drug product
BISOPROLOL FUMARATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 29300012601
D-542-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 299 Tablets
- Official record key
drug-enforcement:D-542-2014
Official wording
Reason: Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.
Code information: BISOPROLOL FUMARATE Tablet, 5 mg has the following code Pedigree: AD34934_7, EXP: 5/10/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled