Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

FDA recall notice · announced April 17, 2019 · H J Harkins Company Inc Dba Pharma Pac

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

The product

Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

Reason for recall

CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).

Notes

Distribution: Product was distributed to a physician's office in California.
Lot/code information: Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
Quantity: 300 tablets
Status: Terminated
Products in this recall event:
- Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side. (D-1083-2019)

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