Drug product
CETIRIZINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378363501.
D-906-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-906-2014
Official wording
Reason: Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.
Code information: CETIRIZINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD32757_13, EXP: 5/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled