FDA recall D-1026-2013

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

Product

Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA

Reason for recall

Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to 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-1026-2013