Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
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.
Class II · Moderate risk
buPROPrion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
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