D-0791-2020 Class II Terminated
FDA drug recall D-0791-2020 was initiated by Mylan Pharmaceuticals Inc. on Jan 7, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. The recall status is terminated (terminated May 19, 2021). Affected quantity: 31,736 bottles of 60 capsules.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 29, 2020
- Initiation Date
- Jan 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0791-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026