CLASS II Drug recall · Reported 7 Apr 2021 · FDA Enforcement Report
Zoma-Jet 5 Demonstration Kit recalled by Ferring Pharmaceuticals
Ferring Pharmaceuticals is recalling Zoma-Jet 5 Demonstration Kit, Needle-free delivery device for use with Zomacton, distributed nationwide in the US. The recall was initiated on 11 Mar 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0317-2021
- FDA event ID
- 87455
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2021
- FDA classified
- 30 Mar 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Mar 2021 | Recall initiated by company | |
| 30 Mar 2021 | Classified by FDA | +19 days |
| 7 Apr 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Zoma-Jet 5 Demonstration Kit, Needle-free delivery device for use with Zomacton recalled?
Yes. Ferring Pharmaceuticals recalled Zoma-Jet 5 Demonstration Kit, Needle-free delivery device for use with Zomacton on 11 Mar 2021. The recall is Class II and its status is Terminated. Recall number D-0317-2021.
Why was it recalled?
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Which lots are affected?
201601320031 201702320207 201731220039 201817120044 201912720086 201912320044
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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