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.
Reported: April 17, 2019 Initiated: March 4, 2019 #D-1083-2019
Product Description
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).
Details
- Recalling Firm
- H J Harkins Company Inc dba Pharma Pac
- Units Affected
- 300 tablets
- Distribution
- Product was distributed to a physician's office in California.
- Location
- Grover Beach, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 300 tablets.
Why was this product recalled? ▼
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1083-2019.
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