Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974
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.
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Reason CGMP deviations: Lack of potency testing.
Reason CGMP deviations: Lack of potency testing.
Reason CGMP deviations: Lack of potency testing.
Reason CGMP deviations: Lack of potency testing.
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