Recalls / Class II
Class IID-0791-2020
Product
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
- Affected lot / code info
- Lot Number: 3086746, exp. date May 2020
Why it was recalled
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 31,736 bottles of 60 capsules
- 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.
Timeline
- Recall initiated
- 2020-01-07
- FDA classified
- 2020-01-20
- Posted by FDA
- 2020-01-29
- Terminated
- 2021-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0791-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.