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Safety Report: Delsam Pharma’s Artificial Eye Ointment - recalled due to microbial contamination, USA

1 year ago •source fda.gov

Recall notice

Delsam Pharma’s Artificial Eye Ointment - recalled due to microbial contamination photo #1

United States

Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. The product was distributed nationwide in the United States, and by Delsam through internet retail sites.

Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) is used as an eye lubricant and to relieve dryness of the eyes.

The affected product is packaged in a white aluminum tube within a paper carton. The product can be identified by the photos provided below. Delsam Pharma’s NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3. Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Global Pharma Healthcare
Brand name: Delsam Pharma’s
Product recalled: Artificial Eye Ointment
Reason of the recall: Due to possible microbial contamination
FDA Recall date: February 24, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-delsam-pharma-artificial-eye-ointment

#drugs #recall #us #ro-tel

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