FDA-Drug2023-07-19Class I
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.
Global Pharma Healthcare Private Limited
Hazard
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Sold states
Product was distributed to two distributors who further distributed Nationwide in the USA.
Affected count
400,008 bottles total for all products
Manufactured in
A - 9 Sidco Pharmaceutical Complex, Thiruporur, Chennai, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0921-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief