Reported May 11, 2022 · Terminated
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b)…
Lupin Pharmaceuticals 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: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only
- Manufactured ByLupin Limited, Pithampur, India
- MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
- Lot codes and dates
- Lot #
249 of 249 codes
H0011494/30/202268180-215-06H0016025/31/202268180-215-06H0018846/30/202268180-215-06H0025398/31/202268180-215-06H1009444/30/202368180-215-06H1010544/30/202368180-215-06H0011504/30/202268180-215-09H0011514/30/202268180-215-09H0011524/30/202268180-215-09H0015325/31/202268180-215-09H0015335/31/202268180-215-09H0015345/31/202268180-215-09H0015355/31/202268180-215-09H0015365/31/202268180-215-09H0016035/31/202268180-215-09H0016045/31/202268180-215-09H0016055/31/202268180-215-09H0016065/31/202268180-215-09H0016075/31/202268180-215-09H0016085/31/202268180-215-09
- Lot #
- Amount recalled
- 1,214,016 bottles
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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