Class II · Moderate risk Terminated
*Mitomycin 0.04% Ophth DR eye drops
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
*Morphine 2 mg/mL Cassette
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
C-*Vancomycin Opthal 14 mg drops
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
C-*Albumin Eye Drop 10% S
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class II · Moderate risk Terminated
Buprenorphine Black Cherry 2 mg Troche
Reason Subpotent Drug
Class II · Moderate risk Terminated
Buprenorphine Watermelon 8 mg Troche
Reason Subpotent Drug
Class II · Moderate risk Terminated
Buprexone Banana cream 6-0.6 mg Troche
Reason Subpotent Drug
Class II · Moderate risk Terminated
Levonorgestrel and Ethinyl Estradiol Tablets USP
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class III · Low risk Terminated
Bekyree
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Class II · Moderate risk Terminated
Sotalol HCL Tablets
Reason Presence of particulate matter. presence of metal particles.
Class II · Moderate risk Terminated
Theophylline
Reason CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Class II · Moderate risk Terminated
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class II · Moderate risk Terminated
Epinephrine Injection USP
Reason CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Class II · Moderate risk Terminated
Sodium Chloride 0.9% Injection
Reason CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Class III · Low risk Terminated
PrediniSONE Tablets
Reason Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class II · Moderate risk Terminated
Peppermint Lip Moisturizer
Reason Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.