FDA recall record

SHEET SPF 30 MINERAL Vivier Sheer SPF 30 Mineral With Antioxidants recall — FDA D-0662-2024

Microbial Contamination of Non-Sterile Product

Class IIclassification
D-0662-2024official record ID
Oct 2, 2024report date

Recall record at a glance

Official recordD-0662-2024
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmVivier Pharma, Inc.
Report dateOct 2, 2024
Recall initiation dateSep 3, 2024
Quantity3476 units
LocationVaudreuil-Dorion, Canada

Official product description

Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R

Why the product was recalled

Microbial Contamination of Non-Sterile Product

Distribution information

Nationwide within the United States

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: Letter.

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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