September 2024 FDA Recall Sheet Spf 30 Mineral by Vivier Pharma, Inc.
D-0662-2024 - Microbial Contamination of Non-Sterile Product

This Class II drug recall was voluntarily initiated by Vivier Pharma, Inc. on September 3, 2024 for the product Sheet Spf 30 Mineral. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0662-2024

Reason for Recall
Microbial Contamination of Non-Sterile Product
Initiated
09-03-2024
Reported
10-02-2024
Quantity
3476 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95339
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Vivier Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 91771, Exp. Date 09/2025

Affected Packages Involved in this Recall

67226-2232-6 Sheet Spf 30 Mineral