Why it was recalled
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Product description
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.
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0318-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2021
- FDA report date
- Apr 7, 2021
- Quantity
- 1569 devices
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ferring Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0318-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87455
- Address
- 100 Interpace Pkwy
- Code information
- 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
- Postal code
- 07054-1149
- Report date
- Apr 7, 2021
- Product type
- Drugs
- Recall number
- D-0318-2021
- Classification
- Class II
- Recalling firm
- Ferring Pharmaceuticals Inc
- Product quantity
- 1569 devices
- Termination date
- Jun 7, 2023
- Reason for recall
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 11, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2021