Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Mei...

FDA Recall #D-0340-2026 — Class II — February 9, 2026

Recall #D-0340-2026 Date: February 9, 2026 Classification: Class II Status: Ongoing

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.

Reason for Recall

Defective Delivery System: Missing or duplicated needles within the injection kit

Recalling Firm

Meitheal Pharmaceuticals, Inc — Chicago, IL

Classification

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

Product Type

Drugs

Product Quantity

16,477 kits

Distribution

U.S. Nationwide

Code Information

Lot Q4E0112A, Exp.: 30 Apr 2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated