FDA recall D-0317-2021

Product

ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.

Reason for recall

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-03-11

Report date

2021-04-07

Termination date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0317-2021