FDAClass IINovember 27, 2019

Altaire Diclofenac Sodium Opthalmic Solution recall: Sterility Concern

Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05

Why was Altaire Diclofenac Sodium Opthalmic Solution 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?

17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21

Product
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
49527 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls