Drug recall D-0792-2020

Class II Terminated reported Jan 29, 2020

Product

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

Reason for recall

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

Lots and codes

Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
16,944 bottles of 30 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