BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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.
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
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 |
|---|---|---|---|---|
| Vista Gonio Eye Lubricant Hypromellose Ophthalmic Solution NDC 77790-0022 |
HYPROMELLOSE 2208 (100 MPA.S) 25 mg/15mL | Solution Ophthalmic |
Red Wedding LLC | 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.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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