FDA-Drug2017-11-01Class III

ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.

Aidarex Pharmaceuticals LLC
Hazard

Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

Sold states
Product was distributed in Florida
Affected count
12 bottles
Manufactured in
595 N Smith Ave Ste B, N/A, Corona, CA, United States
Products
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2018

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