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
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
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
Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class III · Low risk
Cytotec (misoprostol)
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months