The Recall Desk
CriticalFDA (Drugs)·D-0921-2023·Announced 2023-07-19

Artificial Tears Eye Drops Recalled for Bacterial Contamination

Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall carries an FDA Class I designation, the agency's highest-priority classification. FDA analysis confirmed bacterial contamination in unopened products, which for sterile drugs like eye drops represents a serious defect.

Plain-English summary

Delsam Pharma Llc is recalling Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops distributed nationwide. The FDA found unopened bottles to contain bacterial contamination.

The affected product is a 1/2 fl oz (15 ml) bottle containing carboxymethylcellulose sodium 1%. Affected lot numbers are PCMH001, PCMH002, PCMH005, and PCMH007 with an expiration date of November 2023. Approximately 400,008 bottles were distributed to consumers nationwide.

Consumers who have this product with the affected lot numbers should not use it. If you have questions about whether your product is affected, contact Delsam Pharma Llc.

The recalled product

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.
Manufacturer
Global Pharma Healthcare Private Limited
Category
Drug — Eye Drops
Hazard
Affected units
400,008

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Global Pharma Healthcare Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Global Pharma Healthcare Private Limited

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Same hazard · bacterial contamination

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