Mylan Pharmaceuticals has issued a voluntary nationwide recall of three lots of Nizatidine Capsules due to a substance that could cause cancer.
Three lots of Nizatidine Capsules, USP, (including the 150mg and 300mg strengths), have been recalled due to detected trace amounts of an impurity of NDMA (nitrosodimethylamine).
NDMA is a known contaminant that can be found in water and foods, and has been classified as as possible substance that could cause cancer.
Here is the full release:
Mylan N.V.External Link Disclaimer(NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is 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 Limited.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches 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:
NDC Product Description Strength Size Lot Number Expiry 0378-5150-91 Nizatidine Capsules, USP 150mg Bottles of 60 3086746 May 2020 0378-5300-93 Nizatidine Capsules, USP 300mg Bottles of 30 3082876 Jan 2020 0378-5300-93 Nizatidine Capsules, USP 300mg Bottles of 30 3082877 Jan 2020
Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 888-628-0727 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online by regular mail or by fax.
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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.