Class II · Moderate risk
Phenylephrine Hydrochloride Ophthalmic Solution
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
Dextroamphetamine Sacharate
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class II · Moderate risk
Povidone Iodine
Lack of sterility assurance.
Class II · Moderate risk
Major Infants' Gas Relief Drops
Microbial Contamination of Non-Sterile Product.
Class II · Moderate risk
Lidocaine Hydroclhoride Jelly USP
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 I · High risk
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class III · Low risk
Sodium Chloride Injection USP 0.9%
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
Optiray 320
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
Fentanyl Citrate USP
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Class II · Moderate risk
Isoproterenol HCL
Lack of Assurance of Sterility
Class II · Moderate risk
L-Asparaginase Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 9A/B Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 9 Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 5 B
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 10 D Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 10 B Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
SUCCinylcholine Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
SUCCinylcholine Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
SUCCinylcholine Chloride
Lack of Assurance of Sterility