FDA-Drug2014-05-21Class II
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
Teva Pharmaceuticals USA
Hazard
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Sold states
Nationwide
Affected count
2532 bottles
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1293-2014Don't want to check this manually?
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