Drug product
CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
D-472-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 298 Tablets
- Official record key
drug-enforcement:D-472-2014
Official wording
Reason: Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: W003750, EXP: 6/26/2014.
Code information: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) has the following code Pedigree: W003720, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled