D-1463-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2019
- Initiation Date
- June 14, 2019
- Termination Date
- February 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,955 bottles (1,345,950 tablets)
Product Description
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Distribution Pattern
US Nationwide One (1) US government account. No foreign accounts.
Code Information
Lot #: GS017651, Expiration 01/2020