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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ferring Pharmaceuticals Inc
- Reason for Recall:
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0318-2021
Related Recalls
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
Ferring Pharmaceuticals
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP