Lubricant Eye Drops

BRS Analytical Services, LLC faces a Class II FDA recall (D-0407-2025) for 13,104 cases of Lubricant Eye Drops Solution due to cGMP deviations and sterility assurance failures. This nationwide recall impacts distributors like AvKARE, demanding urgent supply chain adjustments and rigorous quality reviews for all ophthalmic product procurement to mitigate significant business and reputational risks.

Brassica Pharma Pvt Ltd faces a Class II FDA recall for 159,334 units of CVS Health Lubricant Eye Ointment due to a lack of sterility assurance. This follows a similar recall for Equate Eye Ointment, signaling systemic quality control deficiencies at its Thane, India facility. Procurement and regulatory teams must reassess Brassica Pharma as a supplier, given the recurring sterility concerns impacting critical ophthalmic products distributed in the U.S.

Brassica Pharma Pvt Ltd faces an FDA Class II recall for 315,842 units of Equate Lubricant Eye Ointment due to sterility assurance failures. This impacts Walmart's supply chain and necessitates immediate action for procurement and regulatory teams. Businesses must assess their supplier qualification processes, identify alternative sterile ophthalmic product manufacturers, and mitigate potential supply disruptions from Indian facilities.