Product: INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Reason for recall: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Recall initiated: 20140324
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated