Drug product
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
D-1294-2014
Product summary
- Event
- Event 67811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,694 bottles
- Official record key
drug-enforcement:D-1294-2014
Official wording
Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Code information: TE32134, Exp. 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations