April 2023 FDA Recall Fyremadel by Sun Pharmaceutical Industries Ltd.
D-0569-2023 - Presence of Particulate Matter

This Class II drug recall was initiated by Sun Pharmaceutical Industries Ltd. on April 19, 2023 for the product Fyremadel. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0569-2023

Reason for Recall
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Initiated
04-19-2023
Reported
05-03-2023
Quantity
24194 Prefilled Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92140
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.
Sun Pharmaceutical Industries Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
N/A
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.
N/A
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.
12-13-2023
Product Description About Product Description
Full technical description of the product.
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1

Batch or Lot Expiration Information

Lot# : HAD1190A, Exp. 02/2024

Affected Packages Involved in this Recall

55566-1010-1 Fyremadel