Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
FDA Drug Recalls
635 recalls, newest first
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Autologous Serum Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 15mg/ml Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin HCl 1 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Brilliant Blue G
Lack of Assurance of Sterility
Class II · Moderate risk
Trypan Blue 0.3%
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 150 mg / Phentolamine 5 mg vials
Lack of Assurance of Sterility
Class II · Moderate risk
Moxi/Dex/Ketorolac 0.5%/0.1%/0.4%
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.5% + Dexamethazone 0.1%
Lack of Assurance of Sterility
Class II · Moderate risk
Apomorphine HCl 3mg/ml Sterile Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Buprenorphine
Lack of Assurance of Sterility
Class II · Moderate risk
Chlorpheniramine Maleate 10 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Human Chorionic Gonadotropin Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Acetylcyst 10% OPHT SOL
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Class II · Moderate risk
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Class II · Moderate risk
TESTOSTERONE CYPIONATE 200mg/ml
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Class II · Moderate risk
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.