Drug product
chlorproMAZINE HCl, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030300.
D-1015-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-1015-2014
Official wording
Reason: Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ACYCLOVIR, Tablet, 800 mg, NDC 00093894701, Pedigree: AD70629_1, EXP: 5/29/2014; TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD70625_1, EXP: 5/29/2014.
Code information: chlorproMAZINE HCl, Tablet, 100 mg has the following codes: Pedigree: AD70629_4, EXP: 5/29/2014; Pedigree: AD70700_1, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled