Drug product
TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601
D-612-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Capsules
- Official record key
drug-enforcement:D-612-2014
Official wording
Reason: Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014; SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014.
Code information: TRIMETHOBENZAMIDE HCl, Capsule, 300 mg has the following codes Pedigree: AD21858_10, EXP: 5/1/2014; Pedigree: AD70625_1, EXP: 5/29/2014; Pedigree: W002976, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled