Class I · High risk Terminated
Hcg 6
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Human Chorionic Gonadotropin 11
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
What was recalled
Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0177-2018
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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