PlainRecalls
FDA Drug Moderate Class II Terminated

Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183

Reported: September 25, 2013 Initiated: August 23, 2013 #D-1048-2013

Product Description

Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183

Reason for Recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Details

Recalling Firm
Medaus, Inc.
Units Affected
1198 mL
Distribution
Nationwide
Location
Birmingham, AL

Frequently Asked Questions

What product was recalled?
Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183. Recalled by Medaus, Inc.. Units affected: 1198 mL.
Why was this product recalled?
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 25, 2013. Severity: Moderate. Recall number: D-1048-2013.