Class II · Moderate risk Terminated
Moxi/Dex/Ketorolac 0.5%/0.1%/0.4%
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Moxifloxacin 0.5% + Dexamethazone 0.1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Apomorphine HCl 3mg/ml Sterile Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Buprenorphine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Chlorpheniramine Maleate 10 mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Venlafaxine HCL ER Capsule USP
Reason Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk Terminated
Venlafaxine HCL ER Capsule USP
Reason Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk Terminated
Bactroban Ointment
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Bactroban Nasal
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Bactroban Cream
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Bactroban Cream
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Trokendi XR
Reason Superpotent Drug: Failure of assay specifications in the capsule.
Class II · Moderate risk Terminated
Dextroamphetamine Sulfate Extended-Release Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Acetylcyst 10% OPHT SOL
Reason Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Class II · Moderate risk Terminated
Metronidazole 500mg Tablet
Reason CGMP Deviations
Class II · Moderate risk Terminated
Doxycycline100mg Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Acyclovir 400mg Tablet
Reason CGMP Deviations
Class II · Moderate risk Terminated
Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Atorvastatin Calcium 40mg Tablet
Reason CGMP Deviations
Class II · Moderate risk Terminated
Acetaminophen 325mg tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Oxygen Nasal Wash
Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class II · Moderate risk Terminated
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Reason Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk Terminated
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Reason Marketed without an approved NDA/ANDA: Undeclared sibutramine.