Recalls / Class II
Class IID-0792-2020
Product
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
- Affected lot / code info
- Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 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
- 16,944 bottles of 30 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-0792-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.