Drug product
BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516.
D-981-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 CHEW Tablets
- Official record key
drug-enforcement:D-981-2014
Official wording
Reason: Labeling: Label Mixup: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 00093746556, Pedigree: AD42592_7, EXP: 5/14/2014.
Code information: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg has the following codes: Pedigree: AD42592_10, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled