Drug & medication recalls Moderate risk

OCuSOFT Tears Again Lubricant Eye Drops recalled over sterility concerns

Recall date
July 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Altaire Pharmaceuticals, Inc. recalls OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 U…
Recall number
D-0450-2020
FDA classification
Class II
Brand / firm
Altaire Pharmaceuticals, Inc.
Sold / distributed
U.S.A. Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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