Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
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.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.