FDA recall D-0414-2015

Mutual Pharmaceutical Company, Inc. · Class II · drug

Product

Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01

Reason for recall

Failed Impurities/Degradation Specifications: during long-term stability testing.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-03-10
Report date: 2015-03-25
Termination date: 2016-07-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0414-2015