D-0791-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- May 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,736 bottles of 60 capsules
Product Description
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.
Distribution Pattern
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.
Code Information
Lot Number: 3086746, exp. date May 2020