Drug product
CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
D-474-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-474-2014
Official wording
Reason: Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD46265_10, EXP: 5/15/2014.
Code information: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) has the following code Pedigree: AD46257_43, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled