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Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ...

FDA Recall #D-0921-2023 — Class I — January 30, 2023

Recall #D-0921-2023 Date: January 30, 2023 Classification: Class I Status: Ongoing

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

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

Recalling Firm

Global Pharma Healthcare Private Limited — Chennai, N/A

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

400,008 bottles total for all products

Distribution

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

Code Information

Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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