Class II · Moderate risk
Ganirelix Acetate Injection
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Fyremadel (ganirelix acetate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Affected NDC
55566-1010-01
Compare with the code on your package — it is the most precise check available.
Drug: Ganirelix
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Fyremadel ganirelix acetate NDC 55566-1010 |
250 ug/.5mL | Injection, Solution Subcutaneous |
Ferring Pharmaceuticals Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries Ltd.
- NDC code
- 55566-1010-1
- Origin
- N/A, India
- Initiated by
- N/A
- FDA recall number
- D-0569-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ganirelix recalls
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Class II · Moderate risk
Ganirelix Acetate Injection
Failed Impurities/Degradation Specifications
Other recalls by Sun Pharmaceutical Industries Ltd.
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