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
- bacterial-contamination
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.
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