Recalls / Class II
Class IID-0662-2024
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
- Brand name
- Sheet Spf 30 Mineral
- Generic name
- Titanium Dioxide, Zinc Oxide
- Active ingredients
- Titanium Dioxide, Zinc Oxide
- Route
- Topical
- NDC
- 67226-2232
- FDA application
- M020
- Affected lot / code info
- Lot #: 91771, Exp. Date 09/2025
Why it was recalled
Microbial Contamination of Non-Sterile Product
Recalling firm
- Firm
- Vivier Pharma, Inc.
- Manufacturer
- Vivier Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 288 Adrien-Patenaude St, Vaudreuil-Dorion, N/A, Canada
Distribution
- Quantity
- 3476 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-09-03
- FDA classified
- 2024-09-20
- Posted by FDA
- 2024-10-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0662-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.