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

Recalled November 1, 2017 · FDA recall D-0053-2018 · Aidarex Pharmaceuticals

Hazard

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

Units

12 bottles

Sold at

Product was distributed in Florida

Description

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

Product

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

Manufacturer(s)

Aidarex Pharmaceuticals LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →