Class I · High risk Terminated
Hcg 6
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Chorionic Gonadotropin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
What was recalled
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Recalling firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Origin
- OR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0182-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Chorionic recalls
See all
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 1
Reason CGMP deviations: Lack of potency testing.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 5
Reason CGMP deviations: Lack of potency testing.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 6
Reason CGMP deviations: Lack of potency testing.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 11
Reason CGMP deviations: Lack of potency testing.
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