Teva Pharmaceuticals USA recalls INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manu
Recalled May 21, 2014 · FDA recall D-1295-2014 · Teva Pharmaceuticals USA
Hazard
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. · FDA Class II
Units
5812 bottles
Sold at
Nationwide
Description
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
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
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →