Home / Recalls / Ferring Pharmaceuticals Inc / D-0317-2021

D-0317-2021 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
301 devices

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.

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

201601320031 201702320207 201731220039 201817120044 201912720086 201912320044

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-0318-2021 Class II — ZOMA-Jet 10 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)