FDAClass IINovember 27, 2019

Puralube Ophthalmic Ointment recall: Sterility Concern

Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20

Why was Puralube Ophthalmic Ointment 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?

RKM 11/19 SGA 7/20 SIF 9/20 SKE 11/20

Product
Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
195,864 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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