Reported May 11, 2022 · Terminated
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) 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, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only
- Manufactured ByLupin Limited, Pithampur, India
- MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
- Lot codes and dates
- Lot #
429 of 429 codes
H0011564/30/202268180-217-06H0016275/31/202268180-217-06H0019476/30/202268180-217-06H0022428/31/202268180-217-06H1018267/31/202368180-217-06H0011554/30/202268180-217-09H0013555/31/202268180-217-09H0013565/31/202268180-217-09H0013575/31/202268180-217-09H0013585/31/202268180-217-09H0013595/31/202268180-217-09H0013715/31/202268180-217-09H0013725/31/202268180-217-09H0013735/31/202268180-217-09H0013745/31/202268180-217-09H0013755/31/202268180-217-09H0016285/31/202268180-217-09H0016295/31/202268180-217-09H0016306/30/202268180-217-09H0016456/30/202268180-217-09
- Lot #
- Amount recalled
- 303,696 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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