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 II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Testosterone 200 mg/Anastrazole 20mg Pellet
Superpotent and Subpotent drugs
Class II · Moderate risk
Testosterone 60 mg/Anastrazole 4 mg Pellet
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 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 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 II · Moderate risk
Ondansetron HCI API
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Irrigating Solution
Lack of assurance of sterility
Class II · Moderate risk
Phenylephrine HCI Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule