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
    • 76519-1033-03
    • Pharma Pac Lot # LTO00EW
    • Exp. 11/19
    • MFG NDC 31722-0702-30
    • MFG Lot # LOP17087
    • Exp. 11/2019
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 24, 2023 · Data as of Sep 19, 8:01 PM UTC

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