FDA-Drug2023-07-19Class II
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
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.
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-0922-2023Don't want to check this manually?
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