Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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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