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Safety Report: Brassica Pharma Pvt. Ltd. Eye ointment products - recalled due to Due to Potential Lack of Sterility Assurance., USA
8 months ago •source fda.gov
Recall notice
United States
Company name: Brassica Pharma Pvt. Ltd.Brand name: Multiple brands
Product recalled: Eye ointment products
Reason of the recall: Due to Potential Lack of Sterility Assurance.
FDA Recall date: February 26, 2024
Recall details: Company Announcement FOR IMMEDIATE RELEASE – 12 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with 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 Food and Drug Administration (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 16th February 2024 related to this recall.
Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brassica-pharma-pvt-ltd-issues-voluntary-nationwide-recall-equate-lubricant-eye-ointment-equate-stye
Source: FDA