FDAClass IINovember 27, 2019

OCuSOFT Flucaine Proparacaine Hydrochloride and recall: Sterility Concern

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc.…

Why was OCuSOFT Flucaine Proparacaine Hydrochloride and 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?

17255 8/20 17362 12/20 18089 4/21 18138 6/21 6/22/2018 18146 6/21 18210 8/21 18211 8/21 18272 11/21 18273 11/21 18276 11/21 16283 10/31/2019

Product
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc.…
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
427,280 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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