Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
18,003 recalls, newest first
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
CGMP Deviations:
Failed Stability Specifications
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.