Recalls / Class II
Class IID-806-2014
Product
PREGABALIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101768.
- Affected lot / code info
- Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg has the following codes: Pedigree: AD21787_1, EXP: 5/1/2014; Pedigree: AD30024_1, EXP: 5/9/2014; Pedigree: AD73518_4, EXP: 5/31/2014; Pedigree W002759, EXP: 6/6/2014; Pedigree: W003397, EXP: 6/19/2014; Pedigree: W003398, EXP: 6/19/2014.
Why it was recalled
Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00781570192, Pedigree: AD21965_10, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD30180_25, EXP: 5/9/2014; clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00093083201, Pedigree: AD73518_1, EXP: 5/31/2014; OM
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 540 Capsules
- 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-806-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.