ChemLifeIntel/Companies/Brassica Pharma Pvt Ltd

Brassica Pharma Pvt Ltd

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Showing 2 of 2 briefs on Brassica Pharma Pvt Ltd

REGULATORY INTELLIGENCE·Warning Letter

Brassica Pharma Faces Second FDA Recall for Eye Ointment Sterility, Escalating Supply Chain Risk

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.

90-Day Activity

Brassica Pharma PvtLubricant Eye Drops

PSPriya Subramaniam· Intelligence Analyst

2024-03-06▲ Trending signal

REGULATORY INTELLIGENCE·Recall

FDA Class II Recall: Brassica Pharma's Equate Eye Ointment Faces Sterility Assurance Failure, Impacting Walmart Supply Chain

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.

90-Day Activity

Brassica Pharma PvtLubricant Eye Drops

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-03-06