FDA-Drug2020-01-29Class II
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Mylan Pharmaceuticals Inc.
Hazard
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Sold states
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
Affected count
31,736 bottles of 60 capsules
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0791-2020Don't want to check this manually?
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