🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: September 5, 2017 Aidarex Pharmaceuticals Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot #: 55097-2, 56085-1, Exp 11/30/2018
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aidarex Pharmaceuticals LLC
Reason for Recall:
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0053-2018

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