Reported May 11, 2022 · Terminated
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (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 Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only
- MFRMacleods Pharma USA, Inc. Plainsboro, NJ 08536
- Lot codes and dates
Lot # BLI2002Aexp. date 11/2022 BLI2004Aexp. date 11/2022 BLI2104Bexp. date 05/2023
- Amount recalled
- 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
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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