Fyremadel Ganirelix Acetate Injection Recalled for Glass Contamination
Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves glass contamination in an injectable medication, which constitutes a risk-of-harm product per the rubric. No illnesses or injuries are reported in the source text. The rubric places risk-of-harm products where injury has not yet been reported at Score 3.
Plain-English summary
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, is being recalled due to the presence of particulate matter. A piece of glass was found in a prefilled syringe from lot HAD1190A, which expires 02/2024. The product is manufactured by Sun Pharmaceutical Industries Ltd. and distributed by Ferring Pharmaceuticals Inc.
The recall affects 24,194 prefilled syringes distributed nationwide in the United States.
Patients who have received units from the affected lot should contact their healthcare provider immediately. Healthcare providers should not dispense units from lot HAD1190A and should take appropriate measures to identify and isolate units from this lot if they have been dispensed.
Sun Pharmaceutical initiated this Class II recall due to the glass contamination found in the product.
The recalled product
- Product
- FYREMADEL (GANIRELIX ACETATE)
- Brand
- FYREMADEL
- Manufacturer
- Sun Pharmaceutical Industries Ltd.
- Category
- Drug — Prescription Injectable
- Hazard
- Affected units
- 24,194
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: HAD1190A
- Exp. 02/2024
Distribution
Distributed nationwide across the United States.
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