D-0340-2026 Class II Ongoing
FDA drug recall D-0340-2026 was initiated by Meitheal Pharmaceuticals, Inc on Feb 9, 2026 and is designated Class II. Reason for recall: Defective Delivery System: Missing or duplicated needles within the injection kit The recall status is ongoing. Affected quantity: 16,477 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 18, 2026
- Initiation Date
- Feb 9, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,477 kits
Product Description
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.
Reason for Recall
Defective Delivery System: Missing or duplicated needles within the injection kit
Distribution Pattern
U.S. Nationwide
Code Information
Lot Q4E0112A, Exp.: 30 Apr 2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0340-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026