FDA DrugsClass II
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx On...
Published: February 18, 2026Recall ID: D-0340-2026Category: drugsCountry: US
Reason for Recall / Hazard
Defective Delivery System: Missing or duplicated needles within the injection kit
Product Description & Identification
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.
Affected 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Chicago |
| State | IL |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui | 283402 |
| Openfda › Spl id | 1f143808-6446-45a1-9a8c-9e58a26c22cb |
| Openfda › Brand name | CETRORELIX ACETATE |
| Openfda › Spl set id | 9b3057ac-6cac-4509-a355-df76247b992c |
| Openfda › Package ndc › 1 | 71288-558-90 |
| Openfda › Package ndc › 2 | 71288-556-02 |
| Openfda › Package ndc › 3 | 71288-557-81 |
| Openfda › Product ndc | 71288-558 |
| Openfda › Generic name | CETRORELIX ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Manufacturer name | Meitheal Pharmaceuticals Inc. |
| Openfda › Application number | ANDA214540 |
| Openfda › Is original packager | true |
| Event id | 98386 |
| Address 1 | 8700 W Bryn Mawr Ave Ste 600s |
| Address 2 | N/A |
| Code info | Lot Q4E0112A, Exp.: 30 Apr 2027 |
| Postal code | 60631-3529 |
| Report date | 20260218 |
| Product type | Drugs |
| Product quantity | 16,477 kits |
| Reason for recall | Defective Delivery System: Missing or duplicated needles within the injection kit |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260209 |
| Initial firm notification | Letter |
| Center classification date | 20260223 |
Overview
- Recalling FirmMeitheal Pharmaceuticals, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide