Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.
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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