FDAFDA · Food and drugs·Recall number 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 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.
Published April 7, 2021 · Recall initiated: March 11, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ferring Pharmaceuticals Inc
- Distributor
- Nationwide in the USA
- Lot
- 201601320031 201702320207 201731220039 201817120044 201912720086 201912320044
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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