Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
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
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Ascend Laboratories
Failed Dissolution Specifications
Class II · Moderate risk
Oasis Tears PF
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class II · Moderate risk
Similasan
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
iVIZIA
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk
Systane
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk
Naproxen Oral Suspension
Chemical contamination; presence of lead and lithium above specification
Class II · Moderate risk
Optase Dry Eye Intense Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Freshkote Lubricant Eyedrops
Lack of Assurance of Sterility
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
vite20 Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry