Class II · Moderate risk Terminated
Fyremadel
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
FDA Drug Recalls
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Class II · Moderate risk Ongoing
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Reason Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Class III · Low risk Terminated
Avicel DG
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-200 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-102 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-101 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk Ongoing
C-Semaglutide 5mg/mL injection
Reason Lack of assurance of sterility.
Class II · Moderate risk Ongoing
Admelog
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Class III · Low risk Terminated
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Reason Subpotent Drug: Out of specification results for low potency was obtained.
Class II · Moderate risk Completed
Pantoprazole sodium for Injection 40 mg*/vial
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk Terminated
Simvastatin USP 40 mg
Reason CGMP deviations.
Class II · Moderate risk Terminated
Simvastatin USP 20 mg
Reason CGMP deviations.
Class II · Moderate risk Terminated
Glimepiride USP
Reason CGMP deviations.
Class II · Moderate risk Terminated
Simvastatin USP
Reason CGMP deviations.
Class II · Moderate risk Terminated
Montelukast Sodium USP
Reason CGMP deviations.
Class II · Moderate risk Ongoing
Fast Acting Earwax Removal System
Reason CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Class II · Moderate risk Ongoing
Advil Liqui-Gels Solubilized Ibuprofen Capsules
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk Ongoing
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk Ongoing
Advil Ibuprofen Tablets
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk Ongoing
Advil Ibuprofen Tablets
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class III · Low risk Terminated
Norepinephrine Bitartrate Injection
Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III · Low risk Terminated
Dodex Injectable Cyanocobalamin Injection
Reason Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class I · High risk Terminated
SOFT HANDS Alcohol Antiseptic 80%
Reason Chemical Contamination: FDA testing found Presence of methanol
Class I · High risk Terminated
Alcohol Antiseptic 80%
Reason Chemical Contamination: FDA testing found Presence of methanol
Class II · Moderate risk Terminated
Isopropyl Alcohol Antiseptic 75%
Reason CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.