D-1021-2013 Class II Terminated

Recalled by University Compounding Pharmacy — San Diego, CA

FDA drug recall D-1021-2013 was initiated by University Compounding Pharmacy on September 6, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. The recall status is terminated (terminated January 21, 2014). Affected quantity: 965.50 mL.

Recall Details

Product Type
Drugs
Report Date
September 18, 2013
Initiation Date
September 6, 2013
Termination Date
January 21, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
965.50 mL

Product Description

Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

Reason for Recall

Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.

Distribution Pattern

Nationwide

Code Information

Lot #s: 474323, Exp 9/13/2013; 498616, Exp 9/25/2013; 475475, Exp 9/26/2013.