Recalls / Class II
Class IID-994-2014
Product
sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
- Affected lot / code info
- has the following codes: Pedigree: AD65475_19, EXP: 5/28/2014; Pedigree: W003335, EXP: 6/19/2014.
Why it was recalled
Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 299 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-994-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.