PlainRecalls
FDA Drug Moderate Class II 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-0922-2023

Product Description

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.

Details

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?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0922-2023.