Recalls / Class II
Class IID-782-2014
Product
DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
- Affected lot / code info
- DRONEDARONE HCL, Tablet, 400 mg has the following codes: Pedigree: AD52778_52, EXP: 5/20/2014.
Why it was recalled
Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, EXP: 5/20/2014.
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
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-782-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.