Class II
Terminated
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- January 7, 2020
- Posted
- January 29, 2020
- Recall Number
- D-0792-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,944 bottles of 30 capsules
- Firm Location
- Morgantown, WV, United States
Reason for Recall
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
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.
Lot / Code Info
Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020
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