Recalls / Class II
Class IID-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.
- Affected lot / code info
- 201601320031 201702320207 201731220039 201817120044 201912720086 201912320044
Why it was recalled
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Recalling firm
- Firm
- Ferring Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Interpace Pkwy, Parsippany, New Jersey 07054-1149
Distribution
- Quantity
- 301 devices
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-11
- FDA classified
- 2021-03-30
- Posted by FDA
- 2021-04-07
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0317-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.