Product: ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
Reason for recall: Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Recall initiated: 20210311
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated