FDAFDA · Food and drugs·Recall number D-1384-2020
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07
Published July 22, 2020 · Recall initiated: July 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout the United States.
- UPC
- 0368180337072
- Lot
- Batch # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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