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.
Reported: April 7, 2021 Initiated: March 11, 2021 #D-0318-2021
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.
Reason for Recall
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Details
- Recalling Firm
- Ferring Pharmaceuticals Inc
- Units Affected
- 1569 devices
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ferring Pharmaceuticals Inc. Units affected: 1569 devices.
Why was this product recalled? ▼
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 7, 2021. Severity: Moderate. Recall number: D-0318-2021.
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