D-0792-2020 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
- 16,944 bottles of 30 capsules
Product Description
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.
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 # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020