Class II · Moderate risk
phenylephrine in 0.9% Sodium Chloride Inj
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
FDA Drug Recalls
16 recalls, newest first
Class II · Moderate risk
ketamine inj 50 mg per 1 mL
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk
PROFESSIONAL Regener-Eyes
Lack of Sterility Assurance
Class II · Moderate risk
LITE Regener-Eyes
Lack of Sterility Assurance
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk
Bevacizumab
Lack of Sterility Assurance
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Empower Pharmacy
Lack of Assurance of Sterility
Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of assurance of sterility: bags have the potential to leak..
Class II · Moderate risk
Potassium Chloride for Injection Concentrate USP
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class II · Moderate risk
Betimol (timolol ophthalmic solution)
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class II · Moderate risk
Fosaprepitant for Injection 150 mg per vial
Lack of Sterility Assurance: Aseptic process simulation failure.