Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals,
Summary
The FDA issued a Class II for Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx On by Meitheal Pharmaceuticals, Inc. Reason: Defective Delivery System: Missing or duplicated needles within the injection kit.
Details
Source
Drug Recall
External ID
D-0340-2026
Action Date
2026-02-18
Status
Ongoing
Category
drug
Product Description
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Lot/Code Info: Lot Q4E0112A, Exp.: 30 Apr 2027
Quantity Affected: 16,477 kits
Reason for Recall
Defective Delivery System: Missing or duplicated needles within the injection kit
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-09
Company
Chicago, IL
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 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Meitheal Pharmaceuticals, Inc has 2 FDA actions in our database, including 2 recalls.
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 (Meitheal Pharmaceuticals, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Meitheal Pharmaceuticals, Inc have FDA actions?
Meitheal Pharmaceuticals, Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0340-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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