Drug 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.
D-1083-2019
Product summary
- Event
- Event 82574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 tablets
- Official record key
drug-enforcement:D-1083-2019
Official wording
Reason: CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
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.
Distribution pattern: Product was distributed to a physician's office in California.
Derived failure modes
-
Foreign material or chemical contamination
NMBA) impurity
-
Manufacturing or process control
CGMP Deviations