Multi-event March 2021 FDA Recall Drug by Ferring Pharmaceuticals Inc

This Multi-event Class II drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on March 11, 2021 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0318-2021 TERMINATED D-0317-2021 TERMINATED

Recall Number: D-0318-2021

Reason for Recall
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Initiated
03-11-2021
Reported
04-07-2021
Quantity
1569 devices

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87455
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0317-2021

Reason for Recall
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Initiated
03-11-2021
Reported
04-07-2021
Quantity
301 devices

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87455
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 201601320031 201702320207 201731220039 201817120044 201912720086 201912320044