Class II · Moderate risk Ongoing
Diclofenac Sodium Topical Solution USP
Reason Defective Delivery System
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Tizanidine Tablets USP
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk Ongoing
Dry Eye Relief Lubricant Eye Drops
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk Ongoing
Original Eye Drops
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nafcillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Reason Sub-potent Drug
Class II · Moderate risk Ongoing
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
Reason 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 Ongoing
Safe tussin PM
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Pin-Away PYRENTAL PAMOATE
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Colic Calm
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Safe tussin DM
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
FentaNYL 500 mcg
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility