Recalls / Class II
Class IID-949-2014
Product
ISONIAZID, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555007102.
- Affected lot / code info
- 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.
Why it was recalled
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,
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 600 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-949-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.