Fyremadel Injection, Solution
FDA Recall NDC 55566-1010
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fyremadel (NDC 55566-1010). A significant event, classified as Class II, was initiated on Apr 19, 2023 by Ferring Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Particulate Matter: A piece of glass was found in a prefilled syringe."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Apr 19, 2023
May 03, 2023
24194 Prefilled Syringes
Recall Profile & Regulatory Data
Event ID
92140
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries Ltd.
Voluntary / Mandated
N/A
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 13, 2023
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
Batch or Lot Expiration Information
Lot# : HAD1190A, Exp. 02/2024
Affected Packages Involved in this Recall
55566-1010-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
