FDA-Drug2026-02-18Class IIPACKAGING DEFECT

Meitheal Cetrorelix Acetate injection kit recalled for missing or duplicated needles

OTHERNationwide distribution

Stop using Meitheal Cetrorelix Acetate injection kits

Meitheal Pharmaceuticals is recalling Cetrorelix Acetate 0.25 mg injection kits because some contain missing or duplicated needles in the delivery system. This affects lot Q4E0112A with an expiration date of April 30, 2027. The defect could prevent proper injection or cause unsafe handling.

  • Check if you have lot Q4E0112A (expiration April 30, 2027)
  • Stop using affected kits immediately
  • Contact your pharmacy or healthcare provider for a replacement
  • Do not attempt to use a kit with missing or extra needles
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-0340-2026

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