Recalls / Class II
Class IID-868-2014
Product
REPAGLINIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008281.
- Affected lot / code info
- REPAGLINIDE, Tablet, 1 mg has the following codes: Pedigree: AD52387_1, EXP: 5/17/2014; Pedigree: W002855, EXP: 6/7/2014; Pedigree: W003924, EXP: 6/28/2014.
Why it was recalled
Labeling: Label Mixup: REPAGLINIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD52372_1, EXP: 5/17/2014; GUAIFENESIN, Tablet, 200 mg, NDC 00904515460, Pedigree: W002853, EXP: 6/7/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W003923, EXP: 6/28/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 500 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-868-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.