Class II · Moderate risk
Avastin
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
FDA Drug Recalls
1,070 recalls, newest first
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk
Clinimix E 5/20 sulfite-free
Lack of Assurance of Sterility; increased complaints received for leaks
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.
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 I · High risk
Lactated Ringer's Irrigation
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Class II · Moderate risk
Fomepizole Injection
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
5% DEXTROSE Injection
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Class II · Moderate risk
RIFAMPIN for Injection
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Colistimethate for Injection USP
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.