Class II · Moderate risk
Apomorphine HCl 3mg/ml Sterile Injection Solution
Lack of Assurance of Sterility
FDA Drug Recalls
6,161 recalls · Class II, newest first
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.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Quad-Mix #3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vitamin B Complex # 3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vitamin B Complex # 1
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vancomycin 50mg/Ml Ophth Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 6
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 5
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 4
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 2
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.