Class II · Moderate risk
Acetylcysteine Ophthalmic Solution
Lack of sterility assurance.
FDA Drug Recalls
343 recalls, newest first
Class I · High risk
Lubrisine eye drops
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class II · Moderate risk
Human Chorionic Gonadotropin 3000 IU
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class I · High risk
puriton EYE RELIEF DROPS
Non-Sterility: Product manufactured under non-sterile production conditions.
Class II · Moderate risk
Bevacizumab 2.5 Mg/0.1ml
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine 30 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Phenylephrine 25 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Hydromorphone
Lack of assurance of sterility
Class II · Moderate risk
Fentanyl (10 mcg/mL)
Lack of assurance of sterility
Class II · Moderate risk
Morphine (1 mg/mL)
Lack of assurance of sterility
Class II · Moderate risk
Testosterone 200 mg/Anastrozole 20 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 87.5mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 50mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 37.5 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 25 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 200mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 12.5mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 100mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 6 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 25mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 18mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 15mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 12.5mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 10mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Cidofovir injection 375 mg/mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle