FDAClass IINovember 27, 2019

OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile recall: Sterility Concern

OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire…

Why was OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 17198, Exp 7/19; 17199, Exp 7/19; 17233, Exp 8/19; 17337, Exp 11/19; 17338, Exp 11/19; 18248, Exp 10/20

Product
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire…
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
103856 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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