Recalls / Class II
Class IID-0182-2015
Product
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Affected lot / code info
- Lot #: 20140909@5, discard date: 3/8/2015; Lot #: 20140728@57, discard date: 1/14/2015.
Why it was recalled
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.
Recalling firm
- Firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 8560 Sw Salish Ln Ste 100, N/A, Wilsonville, Oregon 97070-9625
Distribution
- Quantity
- 117 vials
- Distribution pattern
- Oregon, Washington
Timeline
- Recall initiated
- 2014-10-06
- FDA classified
- 2014-10-31
- Posted by FDA
- 2014-11-12
- Terminated
- 2015-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0182-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.