Class II · Moderate risk
Big Machine Distillery Hand Sanitizer Non-Sterile Solution…
CGMP Deviation: impurities exceed allowable limits.
FDA Drug Recalls
316 recalls, newest first
Class II · Moderate risk
Tizanidine Hydrochloride Tablet 4mg
Failed Stability Specifications
Class III · Low risk
PANCREAZE (pancrelipase)
Failed Stability Specifications
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Delivery System
Class II · Moderate risk
Tizanidine Tablets USP
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk
Dry Eye Relief Lubricant Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
Original Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class III · Low risk
Tranexamic Acid USP Tablets
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk
Nafcillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Nafcillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Nafcillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Sub-potent Drug
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
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