Recalls / Class II
Class IID-1466-2019
Product
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
- Affected lot / code info
- Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Recalling firm
- Firm
- MAJOR PHARMACEUTICALS
- Address
- 17177 N Laurel Park Dr, Livonia, Michigan 48152-2693
Distribution
- Quantity
- 3,102 Cartons (310,200 tablets)
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-01-10
- FDA classified
- 2019-07-09
- Posted by FDA
- 2019-07-17
- Terminated
- 2023-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1466-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.