FDA Drug Class II — Moderate

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vial, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631, Made in China, NDC: 71288-556-02. Syringe: Sterile Water for Injection, USP, 1 mL, Meitheal Pharmaceuticals, Chicago, IL 60631, Made in China, NDC: 71288-557-81

Hazard

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

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Products

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vi
Brand
Meitheal Pharmaceuticals, Inc
UPC
Lot Q4E0112A, Exp.: 30 Apr 2027

Units Affected

16,477 kits

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