FDA-Drug2022-07-06Class II
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Macleods Pharma Usa Inc
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
Product was distributed nationwide.
Affected count
84/1000 count bottles
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, NJ, United States
Products
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1164-2022Don't want to check this manually?
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