Sun Pharmaceutical Industries Ltd.: Drug Recall

Recall #D-0569-2023 · 04/19/2023

Class II: Risk

Recall Details

Recall Number
D-0569-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Sun Pharmaceutical Industries Ltd.
Status
Terminated
Date Initiated
04/19/2023
Location
Halol, N/A, India
Voluntary/Mandated
N/A
Product Quantity
24194 Prefilled Syringes

Reason for Recall

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

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

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.