Reported Apr 17, 2019 · Terminated
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear…
H J Harkins Company Inc. dba Pharma Pac
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: H J Harkins Company Inc dba Pharma Pac · 1400 W Grand Ave Ste F · Grover Beach, CA · 93433-4221
Is this the product you have?
- 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.
- Lot codes and dates
- Pharma Pac NDC
76519-1033-03Pharma Pac Lot # LTO00EWExp. 11/19MFG NDC 31722-0702-30MFG Lot # LOP17087Exp. 11/2019
- Pharma Pac NDC
- Amount recalled
- 300 tablets
Where it was sold
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).
This product could cause temporary or reversible health problems — stop using it.
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