Class III · Low risk
Auryxia (ferric citrate)
Failed Dissolution Specifications
FDA Drug Recalls
107 recalls · Class III, newest first
Class III · Low risk
Glycopyrrolate Injection
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Class III · Low risk
Oseltamivir Phosphate for Oral Suspension
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Class III · Low risk
Benzphetamine tablets
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk
Testosterone Cypionate Injection
Incorrect Labeling: Incorrect lot number on secondary packaging
Class III · Low risk
Phytonadione Tablets 5mg
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III · Low risk
Mephyton (phytonadione)
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.