Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · Moderate risk
Hydroxocobalamin 1) 1000mcg/mL
Lack of assurance of sterility
Class II · Moderate risk
Methylcobolamin 1) 6500 mcg/0.26mL
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Prostaglandin Rx
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Class II · Moderate risk
Captopril Tablets
Failed Tablet/Capsule Specifications: out of specification for thickness.
Class II · Moderate risk
Domperidone BP
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Class II · Moderate risk
Ergoloid Mesylates
Failed Impurities/Degradation Specifications: during long-term stability testing.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 70/20/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Estriol 5 Estradiol
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.