FDA recall record

Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net recall — FDA D-0361-2020

Lack of Assurance of Sterility

Class IIclassification
D-0361-2020official record ID
Nov 27, 2019report date

Recall record at a glance

Official recordD-0361-2020
CategoryDrug Recalls
ClassificationClass II
FDA record statusCompleted
Recalling firmAltaire Pharmaceuticals, Inc.
Report dateNov 27, 2019
Recall initiation dateJul 2, 2019
Quantity30240 units
LocationAquebogue, NY, United States

Official product description

Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g), Distributed by Walgreen Co. 200 Wilmot Road Deerfield, IL 60015, NDC 0363-7500-50

Why the product was recalled

Lack of Assurance of Sterility

Distribution information

U.S.A. Nationwide

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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