CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
OCuSOFT Tears Again Sterile Lubricant Eye Drops recalled
Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Sterile Lubricant Eye Drops, distributed nationwide in the US. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0451-2020
- FDA event ID
- 83265
- Recalling firm
- Altaire Pharmaceuticals, Aquebogue, NY
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Jul 2019
- FDA classified
- 15 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 2 Jul 2019 | Recall initiated by company | |
| 15 Nov 2019 | Classified by FDA | +136 days |
| 27 Nov 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is OCuSOFT Tears Again Sterile Lubricant Eye Drops recalled?
Yes. Altaire Pharmaceuticals recalled OCuSOFT Tears Again Sterile Lubricant Eye Drops on 2 Jul 2019. The recall is Class II and its status is Completed. Recall number D-0451-2020.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
17208 7/21 17209 7/21 19001 1/23
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Altaire Pharmaceuticals
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|---|---|---|---|---|---|
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