On the heels of notable recent medication recalls like Zantac, the U.S. Food and Drug Administration (FDA) is recalling even more medications due to possible trace elements of NDMA.  NDMA (Nitrosodimethylamine) is a probable human carcinogen, meaning it may cause cancer.  The presence of NDMA in Zantac has made waves throughout the medical community.  It seems like consumers now have much more to worry about.

The latest antacid recalls affect several manufacturers and brands that consumers generally trust.  Here are some of the most recent recalls that consumers should be aware of.

New NDMA-Related Antacid Recalls

The FDA continues to investigate potential NDMA contamination.  The agency is monitoring ranitidine products and will continue to update consumers to antacid recalls.

Denton Pharma Inc. 

Denton Pharma Inc. dba Northwind Pharmaceuticals is voluntarily recalling all unexpired lots of ranitidine.  The recall includes prescription ranitidine products that are packaged in bottles and distributed to pharmacies and healthcare facilities.

• Ranitidine Tablets 150mg – Consumers can identify products in the recall by the NDC number on the label. Affected NDCs include:
  • 70934-017-04
  • 70934-017-20
  • 70934-017-24
  • 70934-017-30
  • 70934-017-90
• Ranitidine Tablets 300mg – Consumers can identify these products by the following NDC numbers:
  • 70934-287-15
  • 70934-287-90

Northwind is notifying customers of the recall and urges healthcare facilities and pharmacies to quarantine products being recalled.  Patients taking these ranitidine products should contact their healthcare provider and stop taking the recalled ranitidine as soon as possible.

Appco Pharma LLC

Appco Pharma is also voluntarily recalling all lots and quantities of Ranitidine Hydrochloride Capsules because of potential NDMA quantities above acceptable limits.  The recall includes prescription-only Ranitidine Hydrochloride used to treat benign gastric ulcers, duodenal ulcers and Zollinger-Ellison Syndrome.

The products in this recall were distributed nationwide.  Healthcare providers, pharmacists and consumers can identify the products by the following:

• Ranitidine Capsules 150mg –
  • NDC: 62559-690-60; Batch 1905225VN;  Quantity 60;  Expiration, Apr-21.
  • NDC: 62559-690-05; Batch 1905226VD;  Quantity 500;  Expiration, Apr-21.
  • NDC: 62559-690-60; Batch 1906295UN;  Quantity 60;  Expiration, May-21.
  • NDC: 62559-690-60; Batch 1906296UN;  Quantity 60;  Expiration, May-21.
  • NDC: 62559-690-60; Batch 1906297UN;  Quantity 60;  Expiration, May-21.
  • NDC: 62559-690-05; Batch 1906298UD;  Quantity 500;  Expiration, May-21.
• Ranitidine Capsules 300mg –
  • NDC: 62559-691-30; Batch 1905227UE;  Quantity 30’s;  Expiration, Apr-21.
  • NDC: 62559-691-30; Batch 1905228UE;  Quantity 30’s;  Expiration, Apr-21.

Appco partners with ANI Pharmaceuticals, Inc.  and the company is being notified of the recall.  Appco is also notifying distributors and customers to discontinue and return the products.

Mylan Pharmaceuticals

Mylan Pharmaceuticals is voluntarily recalling three lots of the antacid Nizatidine.  This is one of few antacid recalls involving a drug other than ranitidine.  According to the FDA announcement, trace elements of NDMA were found in three lots of Nizatidine manufactured by Solara Active Pharma Sciences Limited.

Mylan ships medications nationwide to wholesalers, pharmacies, retailers and distributors.  The products in the recall can be identified by the following:

• Nizatidine Capsules USP 150mg –
  • NDC: 0378-5150-91. Lot number 3086746.  Quantity 60.  Expiration, May 2020.
• Nizatidine Capsules USP 300mg –
  • NDC: 0378-5300-93. Lot number 3082876.  Quantity 30.  Expiration, Jan 2020.
  • NDC: 0378-5300-93. Lot number 3082877.  Quantity 30.  Expiration, Jan 2020.

Mylan is working on notifying all customers and distributors.  The company is arranging for a return of all products affected by this recall.

What to Do About Antacid Recalls

If you regularly take antacids, you are likely concerned about what these antacid recalls mean for your health.  The FDA urges consumers to talk to their healthcare provider about a safe alternative to recalled antacids.  So far, there are no signs of NDMA contamination among the following medications:

• Pepcid (famotidine)
• Tagamet (cimetidine)
• Nexium (esomeprazole)
• Prevacid (lansoprazole)
• Prilosec (omeprazole)

In addition to contacting your healthcare provider, it is advisable to report adverse events to the FDA.  You can do this online via MedWatch: The Safety Information and Adverse Event Reporting Program.  You can also contact the FDA by telephone or fax, and can mail a paper report.

Reporting adverse events helps the FDA track side effects and continue research into potentially dangerous medications and medical devices.  Reports also help the FDA update healthcare providers and other regulatory agencies about trends, risks, benefits and the potential need for a recall.

 

Sources:

• https://www.nbcnews.com/health/health-news/fda-announces-more-recalls-antacids-containing-traces-carcinogen-n1113196
• https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/denton-pharma-inc-dba-northwind-pharmaceuticals-voluntarily-recalls-all-unexpired-lots-its
• https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/appco-pharma-llc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-capsules-150-mg-and-300
• https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace#recall-announcement
• https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program