Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Testosterone Cypionate Injection
Reason Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Class II · Moderate risk Terminated
Estradiol tablets
Reason Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Class II · Moderate risk Terminated
Vivitrol
Reason Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class III · Low risk Terminated
Benazepril HCl Tablets
Reason Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Class II · Moderate risk Terminated
Pioglitazone Hydrochloride Tablets USP 15 mg
Reason Superpotent
Class II · Moderate risk Terminated
DrKids Himasal Natural Nasal Saline Solution
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
DrKids Children's Natural Cough Syrup English Ivy Leaf
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II · Moderate risk Terminated
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx…
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx…
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx…
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Phenylephrine Hydrochloride Ophthalmic Solution
Reason Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
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.
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 I · High risk Terminated
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class III · Low risk Terminated
Sodium Chloride Injection USP 0.9%
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
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