Drug 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.
D-0340-2026
Product summary
- Event
- Event 98386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,477 kits
- Official record key
drug-enforcement:D-0340-2026
Official wording
Reason: Defective Delivery System: Missing or duplicated needles within the injection kit
Code information: Lot Q4E0112A, Exp.: 30 Apr 2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Unknown
Defective Delivery System: Missing or duplicated needles within the injection kit