Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

Class I - Dangerous
💊 Drugs Recalled: November 6, 2019 AuroMedics Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021
  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:
AuroMedics Pharma LLC
Reason for Recall:
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

Product Codes/Lot Numbers:

RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0530-2020

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