FDA Recall D-0662-2024

Vivier Pharma, Inc.

Class II Ongoing 618 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: 91771, Exp. Date 09/2025

Quantity: 3476 units

Reason for recall

Microbial Contamination of Non-Sterile Product

Recall record

Recall number: D-0662-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2024-09-03
Classified by FDA Center: 2024-09-20
FDA published: 2024-10-02
Recalling firm: Vivier Pharma, Inc.

Drug identification

Brand name(s): SHEET SPF 30 MINERAL
Generic name(s): TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer(s): Vivier Pharma Inc.
NDC(s): 67226-2232
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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