FDA-Drug2022-05-11Class II
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), 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
N/A
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, NJ, United States
Products
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0837-2022Don't want to check this manually?
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