Drug product
aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980015101
D-702-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-702-2014
Official wording
Reason: Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP: 5/22/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003764, EXP: 6/26/2014.
Code information: aMILoride HC, Tablet, 5 mg has the following codes Pedigree: AD60272_55, EXP: 5/22/2014; Pedigree: W003686, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled