D-0223-2015 Class II Terminated

Recalled by Oregon Compounding Centers, Inc. dba Creative Compounds — Wilsonville, OR

Recall Details

Product Type
Drugs
Report Date
November 12, 2014
Initiation Date
October 6, 2014
Termination Date
June 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
175 mL

Product Description

TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

Reason for Recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution Pattern

Oregon, Washington

Code Information

Lot #: 20140812@7, discard date: 2/8/2015; Lot #: 20140910@41, discard date: 3/9/2015;