Drug product
Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
D-1504-2016
Product summary
- Event
- Event 74694
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,656 HDPE bottles
- Official record key
drug-enforcement:D-1504-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: AVF0246/A, AVF0247/B, AVF0246/B, AVF0246/C; Exp. 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications