Drug 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
D-1295-2014
Product summary
- Event
- Event 67811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5812 bottles
- Official record key
drug-enforcement:D-1295-2014
Official wording
Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Code information: TE38139, Exp. 08/16, TE39022, Exp. 09/16,
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations