PlainRecalls
FDA Drug Moderate Class II Terminated

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.

Reported: May 3, 2017 Initiated: April 6, 2017 #D-0686-2017

Product Description

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.

Reason for Recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Details

Units Affected
2,156 vials
Distribution
Nationwide in the USA and Puerto Rico
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 2,156 vials.
Why was this product recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 3, 2017. Severity: Moderate. Recall number: D-0686-2017.