Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
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
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Spray
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Rinse
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Rinse
cGMP deviations
Class II · Moderate risk
SnoreStop Naso Spray Bulk
cGMP deviations
Class II · Moderate risk
DoloEar Earache Drops
cGMP deviations
Class II · Moderate risk
Babelyn Diarrhea Drops Homeopathic Remedy
cGMP deviations
Class II · Moderate risk
Bebelyn Colic Drops Homeopathic Remedy
cGMP deviations
Class II · Moderate risk
Arnica 7 Cream
cGMP deviations
Class II · Moderate risk
Kanjo Homeopathic Pain Relief Cream With Arnica
cGMP deviations
Class II · Moderate risk
Amphotericin B Liposome for Injection
Subpotent drug
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class II · Moderate risk
Travoprost Ophthalmic Solution
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Class II · Moderate risk
Levsin injection
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Sodium Chloride 0.9% Injection
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class II · Moderate risk
Pain Reliever
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class II · Moderate risk
Nafcillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Nafcillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Nafcillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Foaming Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility