Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical,
Manufacturer / Brand: Oasis Medical, Inc.
Reason for Recall
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.
Date Issued
Category
Medications
Status
unknown
About Medications recalls
Drug recalls in the United States are overseen by the FDA's Center for Drug Evaluation and Research. They may be initiated voluntarily by the manufacturer or requested by the FDA when contamination, potency issues, or labeling errors are identified. Class I drug recalls — the most serious — involve situations where the product may cause serious injury or death. Before stopping a prescription medication due to a recall, contact your pharmacist or prescriber: for many medications, abrupt discontinuation carries its own risks. Your pharmacy can usually arrange an emergency replacement from an unaffected lot or an alternative manufacturer at no additional cost.
What to do if you're affected
- →Stop taking the medication if it matches the recalled lot number.
- →Contact your doctor or pharmacist before stopping any prescription.
- →Return the product to your pharmacy for a refund or replacement.
- →Call the manufacturer's hotline listed on the official recall notice.
About sterility and contamination recalls
Sterility recalls for medications are issued when injectable, ophthalmic, or other sterile drug products are found to be contaminated with bacteria, fungus, or particulate matter — or when they fail sterility testing. Non-sterile injectable drugs can cause serious infections, sepsis, or meningitis. These recalls are treated as among the most urgent in the pharmaceutical category.
⚠ Stop using the product immediately. If you have already administered the product, monitor for signs of infection including fever, chills, or pain at the injection site, and contact your healthcare provider.
Opens the official government source. Always refer to official sources for the most current information.