FDA recall D-1027-2013

South Coast Specialty Compounding, Inc. · Class II · drug

Product

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

Reason for recall

Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.

Distribution

CA, IN

Key facts

Status: Terminated
Initiation date: 2013-08-23
Report date: 2013-09-18
Termination date: 2013-10-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1027-2013