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Class II · Moderate risk Completed Initiated Jul 2, 2019 (7 years ago)

Ocusoft Tears Again Lubricant Eye Drops

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

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.

What was recalled

Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15

Affected NDC 54799-0904-15

Compare with the code on your package — it is the most precise check available.

Category: Eye Drops & Ophthalmic

Recalling firm
Altaire Pharmaceuticals, Inc.
NDC code
54799-904-15
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0398-2020 · FDA notice

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. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Altaire Pharmaceuticals, Inc.

All 2019 recalls

Other sterility / contamination recalls from 2019

All sterility / contamination recalls