Latanoprost manufacturer received an FDA warning letter.
Latanoprost, a glaucoma medication manufactured by Indoco Remedies, received an FDA warning. The popular medication apparently has experience leakage issues that conflict with FDA standards.
The warning letter was specifically in regards to Latanoprost solutions leaving their Goa, India facility. The warning letter does not specifically call for a halt of shipments from the plant.
The FDA warning letter highlights issues with product leakage when Latanoprost is shipped as well as communication practices between the Goa plant and thier American counterpart.
Many FDA Form 483 observations have been issued to Indian drug makers for failing to meet US FDA standards.
According to the FDA, Form 483 is issued when investigators have observed conditions that they believe may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The company plans on responding to the FDA in the- next 15 days regarding the warning letter. So far there has been no indication of a fall in sales of the drug.