Drug product
ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
D-480-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-480-2014
Official wording
Reason: Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.
Code information: ZINC SULFATE, Capsule, 50 mg has the following code Pedigree: AD30994_8, EXP: 5/9/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled