Recalls / Class II
Class IID-0340-2026
Product
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.
- Brand name
- Cetrorelix Acetate
- Generic name
- Cetrorelix Acetate
- Route
- Subcutaneous
- NDC
- 71288-558
- FDA application
- ANDA214540
- Affected lot / code info
- Lot Q4E0112A, Exp.: 30 Apr 2027
Why it was recalled
Defective Delivery System: Missing or duplicated needles within the injection kit
Recalling firm
- Firm
- Meitheal Pharmaceuticals, Inc
- Manufacturer
- Meitheal Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8700 W Bryn Mawr Ave Ste 600s, N/A, Chicago, Illinois 60631-3529
Distribution
- Quantity
- 16,477 kits
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2026-02-09
- FDA classified
- 2026-02-23
- Posted by FDA
- 2026-02-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0340-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.