Class II · Moderate risk
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Mitomycin 0.02%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Brilliant Blue G 0.025% in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Atropine Sulfate 0.01% in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class III · Low risk
Estradiol 12.5 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 200 mg/Anastrazole 20mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Estradiol 3 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone 12.5 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 60 mg/Anastrazole 4 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone Cholesterol
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 200 mg/Anastrozole 9 mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Marcaine 0.5%
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
Marcaine 0.25%
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 III · Low risk
PREMARIN (conjugated estrogen tablets, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Class III · Low risk
Xanax (Alprazolam)
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules
Superpotent Drug and Subpotent Drug; potency failures obtained
Class II · Moderate risk
Tri-Mix 18/1/10
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials
Lack of Assurance of Sterility; medication was sterilized with a recalled filter