Recalls / Class II
Class IID-1083-2019
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.
- Affected lot / code info
- Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
Why it was recalled
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, N/A, Grover Beach, California 93433-4221
Distribution
- Quantity
- 300 tablets
- Distribution pattern
- Product was distributed to a physician's office in California.
Timeline
- Recall initiated
- 2019-03-04
- FDA classified
- 2019-04-07
- Posted by FDA
- 2019-04-17
- Terminated
- 2023-05-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1083-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.