Drug product
Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), 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-1507-2016
Product summary
- Event
- Event 74694
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,889 HDPE bottles
- Official record key
drug-enforcement:D-1507-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot # AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, AVF0259/C; Exp. 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications