Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Salises Facial Moisturizing Acne Treatment Gel
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Antiperspirant Solution
cGMP Deviations; product does not comply with cGMP requirements
Class III · Low risk
Donnatal
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Class II · Moderate risk
Testosterone USP 99.5%
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Estradiol USP 99.5%
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Hydrochlorothiazide Capsules
Presence of Particulate Matter.
Class II · Moderate risk
PGE 25mcg/ml
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/Phento
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
PGE 30mcg/ml Injection
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
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