FDA recall D-0922-2023

Global Pharma Healthcare Private Limited · Class II · drug

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

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

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-0922-2023