FDAClass IINovember 27, 2019

OCuSOFT Tears Again Lubricant Eye Drops recall: Sterility Concern

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

Why was OCuSOFT Tears Again Lubricant Eye Drops 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?

17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23

Product
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
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
81217 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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