Drug product
LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
D-789-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 Tablets
- Official record key
drug-enforcement:D-789-2014
Official wording
Reason: Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.
Code information: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) has the following codes: Pedigree: AD73525_16, EXP: 5/30/2014; Pedigree: AD21790_25, EXP: 5/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup