FDA-Drug2014-05-21Class II

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01

Teva Pharmaceuticals USA
Hazard

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Sold states
Nationwide
Affected count
7,694 bottles
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1294-2014

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