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Drug FDA Class II Ongoing cGMP deviation

Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

Safecor Health, LLC Published Nov 27, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Safecor Health, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Hazards

Blister Card-Foil Separation · primary

Affected products (1)

Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

3139 boxes

Lot codes: 24A0050
Code info: Lot# 24A0050, exp. date 04/25/2026; 24A0055, exp. date 05/09/2026; 24A0059, exp. date 05/16/2026; 24A0060, exp. date 05/20/2026; 24A0071, exp. date 06/24/2026; 24A0072, exp. date 06/26/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 11, 2024
  2. Published
    Nov 27, 2024
Recall number
D-0057-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.