Delsam Pharma Artificial Eye Ointment Recalled for Bacterial Contamination
Delsam Pharma's Artificial Eye Ointment is being recalled for bacterial contamination in unopened tubes. FDA analysis found non-sterility defects in approximately 50,000 units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum score of Severe (4) per the rubric. No deaths, serious injuries, or reported illnesses are mentioned in the source. The bacterial contamination in unopened tubes represents a genuine safety risk in an ophthalmic product, but without reported adverse events, it does not meet the threshold for Critical (5).
Plain-English summary
Delsam Pharma's Artificial Eye Ointment, manufactured by Global Pharma Healthcare Private Limited, is being recalled due to bacterial contamination discovered by the FDA in unopened tubes. The product has been determined to have a non-sterility defect.
The affected product is identified by NDC 72570 122 35, batch H29, with an expiration date of 11/30/2023. The distributor, Delsam Pharma Lic (Bronx, New York), distributed approximately 50,000 tubes nationwide, primarily through internet sales.
Consumers who have purchased this product should discontinue use immediately and consult with a healthcare provider if they have any questions or concerns regarding their prior use of the product.
The recalled product
- Product
- Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
- Manufacturer
- Global Pharma Healthcare Private Limited
- Category
- Drug — Ophthalmic
- 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 (2)
- Batch # H29
- Exp. Date 11/30/2023
Distribution
Distributed nationwide across the United States.
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