REGULATORY INTELLIGENCE·Recall
Thea Pharma Recalls iVIZIA Eye Drops Nationwide Over Sterility Concerns from French Manufacturer's CGMP Deviations
Thea Pharma, Inc. has initiated a nationwide Class II recall for its Similasan and iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) due to a lack of sterility assurance. This critical action stems from Current Good Manufacturing Practice (CGMP) deviations identified by the FDA during an inspection of the product's manufacturer in France. Procurement and regulatory teams must assess immediate supply chain risks and potential market shortages for ophthalmic solutions.
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