January 31, 2020
Mylan Pharmaceuticals Inc. is recalling more than 48,000 bottles of nizatidine capsules after trace amounts of the probable human carcinogen N-Nitrosodimethylamine (NDMA) were detected in the medication, according to the January 29, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were sent to wholesalers, distributors, retail pharmacies, charitable organizations, and mail-order pharmacies throughout the United States:
- 60-count bottles of nizatidine capsules, 150 mg (NDC 0378-5150-91), from lot 3086746 (Exp. 5/20), and
- 30-count bottles of nizatidine capsules, 300 mg (NDC 0378-5300-93), from lots 3082876 (Exp. 1/20) and 3082877 (Exp. 1/20).
Mylan Pharmaceuticals voluntarily initiated the recall January 7, 2020. On January 20, 2020, the FDA designated the recall Class II. The designation signals that use of the affected medication could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Prescription nizatidine is used in the treatment of ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid.