Enalapril Maleate Tablets recall: Impurity Out of Spec
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Why was Enalapril Maleate Tablets recalled?
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 55097-2, 56085-1, Exp 11/30/2018
- Product
- ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Quantity
- 12 bottles
- Distribution
- Product was distributed in Florida
- Recall date
- November 1, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)