D-0182-2015 Class II Terminated
FDA drug recall D-0182-2015 was initiated by Oregon Compounding Centers, Inc. dba Creative Compounds on October 6, 2014 and is designated Class II. 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 st… The recall status is terminated (terminated June 30, 2015). Affected quantity: 117 vials.
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
- 117 vials
Product Description
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, 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 #: 20140909@5, discard date: 3/8/2015; Lot #: 20140728@57, discard date: 1/14/2015.