Drug product
CALCIUM ACETATE, Tablet, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00574011302.
D-955-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 401 Tablets
- Official record key
drug-enforcement:D-955-2014
Official wording
Reason: Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30028_34, EXP: 5/7/2014; HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, NDC 00574024701, Pedigree: W003614, EXP: 6/25/2014.
Code information: CALCIUM ACETATE, Tablet, 667 mg has the following codes: Pedigree: AD23098_1, EXP: 5/8/2014; Pedigree: W003637, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled