Drug product
ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258013101
D-651-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Capsules
- Official record key
drug-enforcement:D-651-2014
Official wording
Reason: Labeling:Label Mixup; ZINC SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52778_10, EXP: 5/20/2014; CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: W003638, EXP: 6/25/2014.
Code information: ZINC SULFATE, Capsule, 220 mg has the following codes Pedigree: AD52993_34, EXP: 5/20/2014; Pedigree: W003641, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled