FDA recall D-0921-2023

Product

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.

Reason for recall

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

Distribution

Product was distributed to two distributors who further distributed Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2023-01-30

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chennai, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0921-2023