Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use…
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
17,898 recalls, newest first
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Reason Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Lack of assurance of sterility.
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Reason Subpotent Drug: Out of specification results for low potency was obtained.
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity…
Reason Sub-potent drug: assay test result below specifications at 9-month timepoint.
Reason Chemical Contamination: FDA testing found Presence of methanol
Reason Chemical Contamination: FDA testing found Presence of methanol
Reason CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.