Class II · Moderate risk Terminated
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Infant's Grape Flavored Acetaminophen Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Acetaminophen Infant Dye Free Grape Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Acetaminophen Child Strawberry Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Children's Cherry Flavored Acetaminophen Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Children's Grape Flavored Acetaminophen Oral Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Acetaminophen Oral Suspension Grape Flavor
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk Terminated
Pregabalin Capsules
Reason Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution USP
Reason Defective Container
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution USP
Reason Defective Container
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4%
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4%
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class II · Moderate risk Terminated
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 60 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 5 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 20 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility