Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Microplegia
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Calcitriol Injection 2 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Amantadine Hydrochloride Oral Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
XOPENEX (levalbuterol HCl)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Vitamin D Supplement Drops
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.