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Safety Report: Lubricant Eye Drops & Multi-Symptom Eye Drops - recalled due to potential safety concerns, USA

5 months ago •source fda.gov

Recall notice

Lubricant Eye Drops & Multi-Symptom Eye Drops - recalled due to potential safety concerns photo #1

United States

Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. These products were distributed nationwide in the USA to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.

There are corrections in product NDC No for the attached products. Kilitch Healthcare India Limited, is notifying its distributor Velocity Pharma LLC and its distributor Velocity Pharma LLC shall be further notifying the wholesalers and retailers via mail of this voluntary recall and is arranging for return of all impacted products in the list below or the image attached. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the listed products to the place of purchase.

Affected products:
- Product: LUBRICANT GEL DROPS 15 ML. Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V. NDC NO (Wrongly Mentioned in last press release): 11822-9706-5. NDC Nos (Corrected, to be read as) 11822-4540-5. Retailer /Label: Rite Aid.
- Product: LUBRICANT EYE DROPS 15ML (TWIN PACK). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO (Wrongly Mentioned in last press release): 11822-9707-5. NDC Nos (Corrected, to be read as) 11822-4811-5. Retailer /Label: Rite Aid.

In case you experience 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: Kilitch Healthcare India Limited
Brand name: Multiple brands
Product recalled: Lubricant Eye Drops & Multi-Symptom Eye Drops
Reason of the recall: Device & Drug Safety Potential Safety Concerns
FDA Recall date: January 22, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-amendments-last-voluntary-nationwide-recall-press-release

#drugs #recall #us

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