Recalls / Class III
Class IIID-0053-2018
Product
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
- Affected lot / code info
- Lot #: 55097-2, 56085-1, Exp 11/30/2018
Why it was recalled
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Recalling firm
- Firm
- Aidarex Pharmaceuticals LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 595 N Smith Ave Ste B, N/A, Corona, California 92880-6920
Distribution
- Quantity
- 12 bottles
- Distribution pattern
- Product was distributed in Florida
Timeline
- Recall initiated
- 2017-09-05
- FDA classified
- 2017-10-26
- Posted by FDA
- 2017-11-01
- Terminated
- 2017-12-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0053-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.