Recalls / Class II
Class IID-527-2014
Product
LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303
- Affected lot / code info
- LEFLUNOMIDE Tablet, 10 mg has the following codes Pedigree: W002659, EXP: 6/5/2014; Pedigree: W002658, EXP: 6/4/2014.
Why it was recalled
Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 60 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-527-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.