Reported May 11, 2022 · Terminated
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) 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/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only
- Manufactured ByLupin Limited, Pithampur, India
- MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
- Lot codes and dates
- Lot #
288 of 288 codes
H0018786/30/202268180-216-06H0021787/31/202268180-216-06H0026269/30/202268180-216-06H1021499/30/202368180-216-06H0016005/31/202268180-216-09H0016015/1/202268180-216-09H0016255/31/202268180-216-09H0016265/31/202268180-216-09H0017946/30/202268180-216-09H0017956/30/202268180-216-09H0017966/30/202268180-216-09H0017976/30/202268180-216-09H0018796/30/202268180-216-09H0018806/30/202268180-216-09H0018816/30/202268180-216-09H0019426/30/202268180-216-09H0019436/30/202268180-216-09H0019446/30/202268180-216-09H0019456/30/202268180-216-09H0019466/30/202268180-216-09
- Lot #
- Amount recalled
- 2,361,924 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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