Home / Recalls / Ferring Pharmaceuticals Inc / D-0318-2021

D-0318-2021 Class II Terminated

Recalled by Ferring Pharmaceuticals Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
April 7, 2021
Initiation Date
March 11, 2021
Termination Date
June 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1569 devices

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.

Distribution Pattern

Nationwide in the USA

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

Other recalls by Ferring Pharmaceuticals Inc

  • D-0879-2023 Class II — Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vagin (June 12, 2023)
  • D-0317-2021 Class II — ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (March 11, 2021)
  • D-0299-2021 Class III — Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials o (March 2, 2021)
  • D-1505-2020 Class I — Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, R (July 21, 2020)
  • D-1504-2020 Class I — DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, M (July 21, 2020)
  • D-1506-2020 Class I — STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spra (July 21, 2020)
  • D-0015-2016 Class III — Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intr (September 9, 2015)
  • D-1385-2014 Class II — TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, (April 28, 2014)
  • D-1426-2014 Class III — ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufa (September 19, 2013)
  • D-240-2013 Class III — TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription (February 1, 2013)