Class II · Moderate risk Terminated
MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Phenylephrine HCl Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Quad3
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Enanthate in Grapeseed Oil Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ultra-Test
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cypionate in Grapeseed Oil Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 10 mg/mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Placebo for Prednisolone Acetate 1%
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Mitomycin 0.02%
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Brilliant Blue G 0.025% in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Atropine Sulfate 0.01% in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk Terminated
Testosterone 200 mg/Anastrazole 20mg Pellet
Reason Superpotent and Subpotent drugs
Class II · Moderate risk Terminated
Testosterone 60 mg/Anastrazole 4 mg Pellet
Reason Superpotent and Subpotent drugs
Class II · Moderate risk Terminated
Testosterone 200 mg/Anastrozole 9 mg Pellet
Reason Superpotent and Subpotent drugs
Class II · Moderate risk Terminated
Marcaine 0.5%
Reason Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class II · Moderate risk Terminated
Marcaine 0.25%
Reason Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class II · Moderate risk Terminated
Desoximetasone Cream USP
Reason Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class II · Moderate risk Terminated
Desoximetasone Cream USP
Reason Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class II · Moderate risk Terminated
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules
Reason Superpotent Drug and Subpotent Drug; potency failures obtained
Class II · Moderate risk Terminated
Tri-Mix 18/1/10
Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk Terminated
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials
Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter