TOPIC: Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment by Brassica Pharma: Recall - Due to Potential Lack of Sterility
AUDIENCE: Consumer, Health Professional, Pharmacy, Ophthalmology
ISSUE: Brassica Pharma Pvt. Ltd. is recalling eye ointment products with an expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the FDA.
Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to February 16, 2024 related to this recall.
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are marketed for dry eye relief or for temporary relief of discomfort due to irritation, stinging, burning and itching.
RECOMMENDATIONS:
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Consumers should stop using the recalled eye ointment and may return any of the above listed products to the place of purchase.
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Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product.
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Consumers with questions regarding this recall can contact Brassica Pharma Pvt. Ltd. at +1-833-225-9564 or info@brassicapharma.com.
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