Drug & medication recalls Moderate risk

OCuSOFT Tetravisc Forte 0 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 Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO…
Recall number
D-0443-2020
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 Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01

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