FDA recall D-1504-2016

Sun Pharmaceutical Industries, Inc. · Class III · 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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-06-27
Report date: 2016-09-28
Termination date: 2018-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1504-2016