Drug product
GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147089103
D-498-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Capsules
- Official record key
drug-enforcement:D-498-2014
Official wording
Reason: Labeling: Label Mixup; GALANTAMINE HBr ER, Capsule, 8 mg may be potentially mislabeled as FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003508, EXP: 6/21/2014.
Code information: GALANTAMINE HBr ER, Capsule, 8 mg has the following code Pedigree: W003509, EXP: 6/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled