Reported Jul 6, 2022 · Terminated
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC…
Macleods Pharma USA Inc.
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: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009
Is this the product you have?
- 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
- MFRMacleods Pharma USA, Inc. Plainsboro, NJ 08536
- Lot codes and dates
Lot # BLM2114Aexp. date 07/2023
- Amount recalled
- 84/1000 count bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
This product could cause temporary or reversible health problems — stop using it.
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