Product: 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 
Reason for recall: 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.
Recall initiated: 20120823
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated