Class II · Moderate risk
rOPINIRole Tablets USP 0.25 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
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
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP 20 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 801 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Vigabatrin for Oral Solution
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Succinylcholine Chloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 80 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 40 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 20 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 5 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Rosuvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.