D-0053-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 1, 2017
- Initiation Date
- September 5, 2017
- Termination Date
- December 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 bottles
Product Description
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Reason for Recall
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Distribution Pattern
Product was distributed in Florida
Code Information
Lot #: 55097-2, 56085-1, Exp 11/30/2018