ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Reported: November 1, 2017 Initiated: September 5, 2017 #D-0053-2018
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.
Details
- Recalling Firm
- Aidarex Pharmaceuticals LLC
- Units Affected
- 12 bottles
- Distribution
- Product was distributed in Florida
- Location
- Corona, CA
Frequently Asked Questions
What product was recalled? ▼
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.. Recalled by Aidarex Pharmaceuticals LLC. Units affected: 12 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 1, 2017. Severity: Low. Recall number: D-0053-2018.
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