Recalls / Class II
Class IID-869-2014
Product
REPAGLINIDE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008481.
- Affected lot / code info
- REPAGLINIDE, Tablet, 2 mg has the following codes: Pedigree: AD46419_4, EXP: 5/16/2014; Pedigree: AD70639_13, EXP: 5/29/2014; Pedigree: W003925, EXP: 7/1/2014.
Why it was recalled
Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD46419_1, EXP: 5/16/2014; PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121207, Pedigree: AD70639_7, EXP: 5/29/2014; DARUNAVIR, Tablet, 800 mg, NDC 59676056630, Pedigree: W003929, EXP: 7/1/2014.
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-869-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.