Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutane
Summary
The FDA issued a Class II for Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile by Sun Pharmaceutical Industries Ltd.. Reason: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe..
Details
Source
Drug Recall
External ID
D-0569-2023
Action Date
2023-05-03
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: HAD1190A, Exp. 02/2024
Quantity Affected: 24194 Prefilled Syringes
Reason for Recall
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Distribution
Nationwide in the USA
Type: N/A
Recall Initiated: 2023-04-19
Company
Halol, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sun Pharmaceutical Industries Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sun Pharmaceutical Industries Ltd. have FDA actions?
This is the only FDA action we have on record for Sun Pharmaceutical Industries Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0569-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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