Reported Nov 1, 2017 · Terminated

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

Aidarex Pharmaceuticals LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aidarex Pharmaceuticals LLC · 595 N Smith Ave Ste B · Corona, CA · 92880-6920

Is this the product you have?

  • ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only
  • MFGWockhardt Ltd., India
  • Packaged ByAidarex Pharmaceuticals; NDC 33261-0693-90
Lot codes and dates
    • Lot #: 55097-2
    • 56085-1
    • Exp 11/30/2018
Amount recalled
12 bottles

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 1, 2017 · Data as of Sep 19, 6:33 PM UTC

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