Drug product
ISONIAZID, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555007102.
D-949-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 Tablets
- Official record key
drug-enforcement:D-949-2014
Official wording
Reason: Labeling: Label Mixup: ISONIAZID, Tablet, 300 mg may have potentially been mislabeled as one of the following drugs: hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003690, EXP: 6/26/2014; CETIRIZINE HCL, Tablet, 5 mg, NDC 00378363501, Pedigree: AD32757_13, EXP: 5/13/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD32757_47, EXP: 5/13/2014; DULoxetine HCl DR,
Code information: ISONIAZID, Tablet, 300 mg has the following codes: Pedigree: W003691, EXP: 6/26/2014; Pedigree: AD32757_31, EXP: 5/13/2014; Pedigree: AD32757_28, EXP: 5/13/2014; Pedigree: AD60272_70, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled