Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10

FDA recall notice · announced July 17, 2019 · Golden State Medical Supply

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10

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.

Notes

Distribution: US Nationwide One (1) US government account. No foreign accounts.
Lot/code information: Lot #: GS017387, Expiration 01/2020
Quantity: 1,470 bottles (1,470,000 tablets)
Status: Terminated
Products in this recall event:
- Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 (D-1462-2019)
- Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 (D-1465-2019)
- Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 (D-1463-2019)
- Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 (D-1464-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.