Class III · Low risk Terminated
Lidocaine Ointment USP
Reason Failed Stability Specifications: product did not meet viscosity results.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Metformin HCl Extended-Release Tablets
Reason Failed Moisture Limits: Out of specification for water content
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Ongoing
Distributed by: DocRx
Reason Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Class III · Low risk Terminated
Lcl-2-0191
Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk Terminated
Sp-4
Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk Terminated
Macula Pellets Homeopathic Medicine
Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk Terminated
Tremfya
Reason Temperature Abuse
Class III · Low risk Terminated
Romidepsin Injecton
Reason Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Class III · Low risk Terminated
Menopur 75 IU
Reason Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Class III · Low risk Terminated
Cequa
Reason Subpotent
Class III · Low risk Terminated
Methylprednisolone Tablets USP
Reason Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class III · Low risk Terminated
Methacholine Challenge 5-Syringe Test Kits
Reason Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Class III · Low risk Terminated
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion…
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Terminated
Betamethasone Dipropionate Ointment USP
Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk Terminated
Betamethasone Dipropionate Ointment USP
Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk Terminated
Betamethasone Dipropionate Ointment USP
Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk Terminated
Auryxia
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Glycopyrrolate Injection
Reason Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Class III · Low risk Terminated
Oseltamivir Phosphate for Oral Suspension
Reason 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 Terminated
Benzphetamine tablets
Reason 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 Terminated
Testosterone Cypionate Injection
Reason Incorrect Labeling: Incorrect lot number on secondary packaging
Class III · Low risk Terminated
Phytonadione Tablets 5mg
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III · Low risk Terminated
Mephyton
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.