Drug product
METHYLDOPA Tablets USP, 500 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 0093-2932-01
D1292-2014
Product summary
- Event
- Event 67811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22820 bottles
- Official record key
drug-enforcement:D1292-2014
Official wording
Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Code information: TE36053A,TE36063A, Exp. 06/16
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations