Class II · Moderate risk
buPROPrion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
FDA Drug Recalls
948 recalls · Class II, newest first
Class II · Moderate risk
Heparin Sodium
Subpotent: Low anti-factor IIa Potency.
Class II · Moderate risk
Buprenorphine Sublingual Tablets
CGMP Deviations
Class II · Moderate risk
Safe tussin PM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Pin-Away PYRENTAL PAMOATE
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Colic Calm
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Safe tussin DM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL 500 mcg
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Succinylcholine Cl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Famotidine Tablets
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk
Pyrazinamide
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.