Class II · Moderate risk
Papa/Pge1/Phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
Papa/Pge1/Phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Papa/Pge1/Phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Papa/Pge1/Phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
PGE 20mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Papa/Phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Papa+pge1+phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone prop. 200 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Testosterone Cypionate 250 mg/mL Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Nandrolone 200 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Stanozolol 200 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix 20mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Caffeine + Sodium Benzoate 500mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Tri-Mix 10mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Methylcobalamin 1000mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Prostaglandin Pge-1 40mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Class II · Moderate risk
Xanax (alprazolam)
Subpotent Drug
Class II · Moderate risk
Sermorelin 6mg/6mL Lyophilized Powder
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
Testosterone Cypionate
Lack of assurance of sterility