Oasis Medical, Inc. — Class II: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Ma
Oasis Medical, Inc. has initiated a Class II recall for Oasis Tears PF, Preservative-Free Lubricant Eye Drops, due to a lack of assurance of sterility following FDA inspection observations at the manufacturing facility, Excelvision.
This recall affects Oasis Medical, Inc., their contract manufacturer Excelvision, and healthcare providers or distributors managing NDC 42126-6400-1.
A Class II recall for sterility concerns in preservative-free ophthalmic products is a significant compliance event, as these products lack antimicrobial agents to mitigate contamination risks. The source indicates the action originated from facility-level inspectional findings rather than confirmed product contamination, suggesting that regulatory scrutiny of sterile fill-finish operations at CMOs remains a high priority for the FDA.
Affected firms should immediately verify inventory against the specified NDC, quarantine impacted lots, and evaluate the sterility assurance profiles of third-party manufacturers, particularly for preservative-free ophthalmic products.
Class II. Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.. Product: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.. Firm: Oasis Medical, Inc. (Glendora CA United States). Status: Ongoing.
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