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Class III: unlikely to cause harmTerminated

Aidarex Pharmaceuticals ENALAPRIL MALEATE Tablets Recall

ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd

Aidarex Pharmaceuticals LLC · Corona, CA

Risk level
Class III
Reported by FDA
Nov 1, 2017
Recall ID
D-0053-2018
Check your lot numberHow we source this data

Summary

Aidarex Pharmaceuticals recalled ENALAPRIL MALEATE Tablets starting Sep 5, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0053-2018 on Nov 1, 2017. Reason: Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 55097-2, 56085-1, Exp 11/30/2018

Where it was sold

Product was distributed in Florida

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0053-2018
Classification
Class III
Status
Terminated
Recall initiated
Sep 5, 2017
FDA report date
Nov 1, 2017
Quantity
12 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Aidarex Pharmaceuticals LLC

Original FDA data

Every field from FDA enforcement report D-0053-2018, exactly as published.

Show all FDA fields
City
Corona
State
CA
Status
Terminated
Country
United States
Event ID
78106
Address
595 N Smith Ave Ste B
Code information
Lot #: 55097-2, 56085-1, Exp 11/30/2018
Postal code
92880-6920
Report date
Nov 1, 2017
Product type
Drugs
Recall number
D-0053-2018
Classification
Class III
Recalling firm
Aidarex Pharmaceuticals LLC
Product quantity
12 bottles
Termination date
Dec 1, 2017
Reason for recall
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Voluntary / mandated
Voluntary: Firm initiated
Product description
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Distribution pattern
Product was distributed in Florida
Recall initiation date
Sep 5, 2017
Initial firm notification
E-Mail
Center classification date
Oct 26, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0053-2018, published Nov 1, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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