Class I · High risk Terminated
Hcg 6
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
What was recalled
Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0070-2015
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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