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Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syring...

FDA Recall #D-0569-2023 — Class II — April 19, 2023

Recall #D-0569-2023 Date: April 19, 2023 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Sun Pharmaceutical Industries Ltd. — Halol, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

24194 Prefilled Syringes

Distribution

Nationwide in the USA

Code Information

Lot #: HAD1190A, Exp. 02/2024

Status

Terminated

Voluntary / Mandated

N/A

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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