REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: Wizcure Pharmaa's BioGlo Fluorescein Sodium Ophthalmic Strips Face Sterility Assurance Deficiencies
Wizcure Pharmaa Private Limited has initiated a Class II nationwide recall of 184,320 containers of BioGlo Fluorescein Sodium Ophthalmic Strips USP due to a lack of sterility assurance stemming from cGMP non-conformance at manufacturer Omni Lens PVT. Ltd. This event underscores critical supply chain vulnerabilities for sterile ophthalmic products and demands immediate action from procurement and regulatory teams.
90-Day Activity
Wizcure Pharmaa Private Limited
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2026-03-04