PlainRecalls
FDA Drug Moderate Class II Completed

OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15

Reported: November 27, 2019 Initiated: July 2, 2019 #D-0450-2020

Product Description

OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
81217 units
Distribution
U.S.A. Nationwide
Location
Aquebogue, NY

Frequently Asked Questions

What product was recalled?
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 81217 units.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0450-2020.