FDA Drug recall D-0317-2021
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 De…
- FDA Drug
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 De… by Ferring Pharmaceuticals, citing defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0317-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-11 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ferring Pharmaceuticals |
| Distribution | US |
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
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Identifiers
| upc | 355566180315 |
|---|---|
| code_info | 201601320031 201702320207 201731220039 201817120044 201912720086 201912320044 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0317-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.