FDAClass IIMay 3, 2023

Fyremadel recall: Particulate Matter

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile…

Why was Fyremadel recalled?

Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: HAD1190A, Exp. 02/2024

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…
Recalling firm
Sun Pharmaceutical Industries Ltd.
Quantity
24194 Prefilled Syringes
Distribution
Nationwide in the USA
Recall date
May 3, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls