Needle-Free Injection Product Recalled

Ferring Pharmaceuticals Inc is recalling nearly 2000 ZOMA-Jet demonstration kits, citing defective delivery systems in the ZOMA-Jet devices included in the kits. According to the April 7, 2021, US Food and Drug Administration (FDA) Enforcement Report, customers have reported injector pens “breaking apart and disintegrating into pieces.”  

The recall affects the following products, which were manufactured for Ferring Pharmaceuticals, Parsippany, NJ, and distributed throughout the United States:

• ZOMA-Jet 5 demonstration kit, needle-free delivery device for use with Zomacton (somatropin) for injection 5-mg vial (UPC 3 55566 18031 5), with codes 201601320031, 201702320207, 201731220039, 201817120044, 201912720086, and 201912320044; and
• ZOMA-Jet 10 demonstration kit, needle-free delivery device for use with Zomacton (somatropin) for injection 10-mg vial (UPC 3 55566 19031 4), with codes 201827020015, 201826020065, 201835320058, 201835320009, 201834920003, 201835220007, 201901820009, 201901420200, 201902120010, 201901120019, 201901420005, 201901020180, 201901520015, 201900720001, 201900920004, 201904620003, 201902120011, 201904420007, 201904520015, 201904920002, 201905020111, 201904620004, 201905720011, 201907320003, 201907320030, 201907820007, 201907420017, 201910820009, 201915620014, 201910920016, 201910620017, 201910820020, 201911320048, 201911320095, 201913720148, and 201912920021. 

Ferring Pharmaceuticals voluntarily initiated the recall March 11, 2021. The FDA designated the recall Class II on March 30, 2021. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

ZOMA-Jet is a needle-free delivery system for patients treated with the prescription growth hormone Zomacton.

—Jolynn Tumolo