D-1466-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2019
- Initiation Date
- January 10, 2019
- Termination Date
- February 19, 2023
- Voluntary/Mandated
- Product Quantity
- 3,102 Cartons (310,200 tablets)
Product Description
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.
Reason for Recall
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
Distribution Pattern
Nationwide.
Code Information
Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.