FDA Drug Critical Class I Ongoing

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.

Reported: July 19, 2023 Initiated: January 30, 2023 #D-0921-2023

Product Description

Reason for Recall

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Details

Recalling Firm: Global Pharma Healthcare Private Limited
Units Affected: 400,008 bottles total for all products
Distribution: Product was distributed to two distributors who further distributed Nationwide in the USA.
Location: Chennai, N/A

Frequently Asked Questions

What product was recalled? ▼

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.. Recalled by Global Pharma Healthcare Private Limited. Units affected: 400,008 bottles total for all products.

Why was this product recalled? ▼

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 19, 2023. Severity: Critical. Recall number: D-0921-2023.