Sheet Spf 30 Mineral Lotion
FDA Recall NDC 67226-2232
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sheet Spf 30 Mineral (NDC 67226-2232). A significant event, classified as Class II, was initiated on Sep 03, 2024 by Vivier Pharma Inc.. The reported reason for this action was: "Microbial Contamination of Non-Sterile Product"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
September 2024 Class II Recall: Microbial Contamination of Non-Sterile Product
Recall Number
Class II Ongoing
Microbial Contamination of Non-Sterile Product
Sep 03, 2024
Oct 02, 2024
3476 units
Recall Profile & Regulatory Data
Event ID
95339
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Vivier Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 91771, Exp. Date 09/2025
Affected Packages Involved in this Recall
67226-2232-6Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
