Drug recall D-0791-2020

Class II Terminated reported Jan 29, 2020

Product

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

Reason for recall

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Lots and codes

Lot Number: 3086746, exp. date May 2020

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
31,736 bottles of 60 capsules
Distribution
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.
Type
Voluntary: Firm initiated
Recall initiated
January 7, 2020
Terminated
May 19, 2021