S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.
First Royal Care Co. LLC
Lack of Assurance of Sterility
Prescription and over-the-counter medications
First Royal Care Co. LLC
Lack of Assurance of Sterility
Marketed without an Approved NDA/ANDA
Dr. Reddy's Laboratories
CGMP Deviations: Presence of NDMA impurity detected in product.
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Marketed without an Approved NDA/ANDA
Dr. Reddy's Laboratories
CGMP Deviations: Presence of NDMA impurity detected in product.
First Royal Care Co. LLC
Lack of Assurance of Sterility
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Dr. Reddy's Laboratories
CGMP Deviations: Presence of NDMA impurity detected in product.
First Royal Care Co. LLC
Lack of Assurance of Sterility
Mylan Pharmaceuticals
Presence of Foreign Substance
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
First Royal Care Co. LLC
Lack of Assurance of Sterility
Dr. Reddy's Laboratories
CGMP Deviations: Presence of NDMA impurity detected in product.