Class II · Moderate risk
Acetaminophen Infant Dye Free Grape Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Acetaminophen Infant Dye Free Grape Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Strawberry Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Strawberry Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Infant's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Infant Dye Free Grape Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Strawberry Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Cherry Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Oral Suspension Grape Flavor
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Pregabalin Capsules
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
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