PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 18, 2013 Initiated: August 23, 2013 #D-1027-2013

Product Description

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.

Details

Units Affected
117 vials
Distribution
CA, IN
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA. Recalled by South Coast Specialty Compounding, Inc.. Units affected: 117 vials.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 18, 2013. Severity: Moderate. Recall number: D-1027-2013.