Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Evrysdi (risdiplam)
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk
Dry Eye Test
Subpotent Drug
Class III · Low risk
Lidocaine Ointment USP
Failed Stability Specifications: product did not meet viscosity results.
Class III · Low risk
Metformin HCl Extended-Release Tablets
Failed Moisture Limits: Out of specification for water content
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Lcl-2-0191
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk
Sp-4
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk
Macula Pellets Homeopathic Medicine
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk
Tremfya (guselkumab)
Temperature Abuse
Class III · Low risk
Romidepsin Injecton
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Class III · Low risk
Menopur 75 IU
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent
Class III · Low risk
Methylprednisolone Tablets USP
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class III · Low risk
Methacholine Challenge 5-Syringe Test Kits
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
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion…
Failed Impurity/Degradation Specifications
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk
Auryxia (ferric citrate)
Failed Dissolution Specifications
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.