PlainRecalls
FDA Drug Moderate Class II Terminated

TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Reported: September 18, 2013 Initiated: July 26, 2013 #D-1003-2013

Product Description

TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Reason for Recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Details

Units Affected
N/A
Distribution
USA nationwide
Location
Southfield, MI

Frequently Asked Questions

What product was recalled?
TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI. Recalled by Beacon Hill Medical Pharmacy, P.C.. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on September 18, 2013. Severity: Moderate. Recall number: D-1003-2013.