Cetrorelix Acetate for Injection recall (Meitheal Pharmaceuticals, Inc)
DrugClass IIOngoing
Summary: Meitheal Pharmaceuticals, Inc is recalling 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: Defective Delivery System: Missing or duplicated needles within the injection kit.
What is being recalled
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.
Why
Defective Delivery System: Missing or duplicated needles within the injection kit
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot Q4E0112A, Exp.: 30 Apr 2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0340-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 9, 2026 |
| Reported | February 18, 2026 |
| Company | Meitheal Pharmaceuticals, Inc |
| Company location | Chicago, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 16,477 kits |
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