FDA-Drug2026-02-18Class II
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.
Meitheal Pharmaceuticals, Inc
Hazard
Defective Delivery System: Missing or duplicated needles within the injection kit
Sold states
U.S. Nationwide
Affected count
16,477 kits
Manufactured in
8700 W Bryn Mawr Ave Ste 600s, N/A, Chicago, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2026Original summary
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. Defective Delivery System: Missing or duplicated needles within the injection kit Lot Q4E0112A, Exp.: 30 Apr 2027 Distribution: U.S. Nationwide Affected quantity: 16,477 kits
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