FDA-Drug2022-06-01Class II

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

Preferred Pharmaceuticals, Inc.
Hazard

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Sold states
Within the U.S in FL and CA.
Affected count
31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
Manufactured in
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Products
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0891-2022

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