FDA recall D-1506-2016

Product

Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), 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-1506-2016