Reported Mar 27, 2019 · Terminated
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for:…
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 · Plainsboro, NJ · 08536-3030
Is this the product you have?
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only
- Manufactured forMacleods Pharma USA, Inc., Plainsboro, NJ 08536
- Manufactured byMacleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
- Lot codes and dates
Lot BLM715AJul-19
- Amount recalled
- 9695 bottles
Where it was sold
Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
This product could cause temporary or reversible health problems — stop using it.
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