Reported Jul 22, 2020 · Terminated
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin…
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?
- Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc
- Manufactured byLupin Limited, Goa INDIA NDC 68180-336-07
- Lot codes and dates
- Batch #
G808293Aug-20G808284Aug-20G808285Aug-20G808343Aug-20G901201Dec-20G901202Dec-20G906915Jul-21G906913Jul-21G906914Jul-21G002135Jan-22G002849Feb-22
- Batch #
- Amount recalled
- 59,568 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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