Drug product
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
D-1293-2014
Product summary
- Event
- Event 67811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2532 bottles
- Official record key
drug-enforcement:D-1293-2014
Official wording
Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Code information: TE36018, Exp. 06/15
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations