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

Tetcaine

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

Why it was recalled

Lack of Assurance of Sterility

What was recalled

Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

Recalling firm
Altaire Pharmaceuticals, Inc.
NDC code
54799-502-15
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0441-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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