Class II · Moderate risk Terminated
Dextroamphetamine Sacharate
Reason Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Povidone Iodine
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Major Infants' Gas Relief Drops
Reason Microbial Contamination of Non-Sterile Product.
Class II · Moderate risk Terminated
Lidocaine Hydroclhoride Jelly USP
Reason cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Class II · Moderate risk Terminated
Optiray 320
Reason Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class II · Moderate risk Terminated
Fentanyl Citrate USP
Reason CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Class II · Moderate risk Terminated
Isoproterenol HCL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Asparaginase Lyophilized
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin 9A/B Lyophilized
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin 9 Lyophilized
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin 5 B
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin 10 D Lyophilized
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin 10 B Lyophilized
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCCinylcholine Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCCinylcholine Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCCinylcholine Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Citrate 40 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin
Reason Lack of Assurance of Sterility