Class III · Low risk Ongoing
Xelpros
Reason Failed Release Testing: Out of specification for particulate matter test.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Reason Out of specification for assay
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk Completed
Nexlizet
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class III · Low risk Terminated
Digoxin Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Digoxin Tablets
Reason Cross Contamination with Other Products:(mycophenolate mofetil).
Class III · Low risk Ongoing
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk Ongoing
Clindamycin Phosphate
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk Terminated
Mercaptopurine Tablets
Reason Failed Dissolution Specifications: results slightly under spec at at 9-months.
Class III · Low risk Ongoing
HydrALAZINE Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class III · Low risk Ongoing
Nortrel 7/7/7
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Ongoing
Nortrel
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Ongoing
Glimepiride Tablets
Reason Misprint on tablet
Class III · Low risk Ongoing
Glimepiride Tablets
Reason Misprint on tablet
Class III · Low risk Ongoing
Benzonatate Capsules
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Class III · Low risk Terminated
Anoro Ellipta
Reason Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class III · Low risk Terminated
Eprontia
Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Completed
Votrient
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Testosterone Gel
Reason OOS for viscosity