WASHINGTON D.C. — Mylan Pharmaceuticals is conducting a voluntary recall of three lots of Nizatidine Capsules, according to the U.S. Food & Drug Administration (FDA).
The FDA website said three lots of Nizatidine capsules are being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Ltd.
A known environmental contaminant found in water, and foods like meats, dairy products and vegetables, NDMA is classified as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC).
FDA said Nizatidine is used to treat ulcers, gastroesophageal reflux disease and conditions that cause too much stomach acid.
According to FDA, Mylan has not received any reports of adverse events related to these batches.
These batches manufactured by Mylan Pharmaceuticals were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018. The recalled batches are as follows:
0378-5150-91, Nizatidine Capsules USP, 150mg, Bottles of 60, Lot #3086746, Exp. May 2020
0378-5300-93, Nizatidine Capsules USP, 300mg, Bottles of 30, Lot #3082876, Exp. Jan 2020
0378-5300-93, Nizatidine Capsules USP, 300mg, Bottles of 30, Lot #3082877, Exp. Jan 2020
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
FDA said adverse reactions should be reported to their MedWatch Adverse Event Reporting program online, by mail or fax.
- Complete and submit the report OnlineExternal Link Disclaimer
- Regular Mail or Fax: Download formExternal Link Disclaimer or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For complete details on this recall, visit The U.S. Food & Drug Administration here.
Mylan Initiates Voluntary Nationwide Recall of 3 Lots of Nizatidine Capsules, USP, Due to Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited https://t.co/pSd3xmViUT pic.twitter.com/1z5hO7rL3f
— U.S. FDA (@FDArecalls) January 9, 2020