HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
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.
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Oasis Tears PF Preservative-Free Lubricant Eye Glycerin NDC 42126-6400 |
.25 g/100mL | Solution/ Drops Ophthalmic |
OASIS Medical, Inc. | OTC |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Falied pH specification
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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