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.
FDA Drug Recalls
6,161 recalls · Class II, newest first
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
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.
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk
Phen 15 mg - Topri 92 mg SR Cap
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Hydrocortisone 1.6 mg/0.5 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Nystatin 50
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Coconut Oil Suppository
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Cyclandelate 200 mg Caps
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Triest 5 mg - Progest 150 mg Capsule
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.