Why it was recalled
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Product description
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.
Lot numbers, UPCs & expiration codes
201601320031 201702320207 201731220039 201817120044 201912720086 201912320044
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-0317-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2021
- FDA report date
- Apr 7, 2021
- Quantity
- 301 devices
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ferring Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0317-2021, 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
- 201601320031 201702320207 201731220039 201817120044 201912720086 201912320044
- Postal code
- 07054-1149
- Report date
- Apr 7, 2021
- Product type
- Drugs
- Recall number
- D-0317-2021
- Classification
- Class II
- Recalling firm
- Ferring Pharmaceuticals Inc
- Product quantity
- 301 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 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 11, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2021