CLASS II Drug recall · Reported 7 Apr 2021 · FDA Enforcement Report
Zoma-Jet 10 Demonstration Kit recalled by Ferring Pharmaceuticals
Ferring Pharmaceuticals is recalling Zoma-Jet 10 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-0318-2021
- 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 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Which lots are affected?
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 201912920021
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87455| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zoma-Jet 5 Demonstration Kit recalled by Ferring Pharmaceuticals | Ferring Pharmaceuticals | Other | Nationwide |
More recalls from Ferring Pharmaceuticals
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Endometrin (progesterone) Vaginal Insert 100mg recalled | Ferring Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Zoma-Jet 5 Demonstration Kit recalled by Ferring Pharmaceuticals | Ferring Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Menopur 75 IU, (menotropins for injection) recalledMenopur | Ferring Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Ddavp Nasal Spray (desmopressin acetate) 10 mcg recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Desmopressin Acetate Nasal Spray 10 mcg/ glass vial with spray cap recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |