Reported Jul 22, 2020 · Terminated
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 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, 100 count bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc
- Manufactured byLupin Limited, Goa INDIA NDC 68180-338-01
- Lot codes and dates
- Batch#
G808201Aug-20G808202Aug-20G808200Aug-20G900935Dec-20G901311Dec-20G900957Dec-20G900958Dec-20G901006Dec-20G904803May-21G904804May-21G906551Jul-21G906552Jul-21G907375Aug-21G908605Oct-21G908604Oct-21G002108Jan-22G002109Jan-22G002559Feb-22G002560Feb-22
- Batch#
- Amount recalled
- 64,344 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Lupin Pharmaceuticals Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.