The Recall Desk
Agency classClass IIIOur severity:LowFDA (Food)·F-0606-2017·Announced 2016-12-14

Safecor Vitamin B-1 Tablets Recalled for Incorrect Ingredient Labeling

Safecor Health is recalling Vitamin B-1 tablets because the boxes are labeled with the wrong chemical form of thiamine.

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the chemical form of the ingredient.

Plain-English summary

Safecor Health, LLC is voluntarily recalling 1,431 boxes of Safecor Vitamin B-1 (THIAMINE) 100 mg tablets. The recall is due to a labeling error where the boxes are labeled as containing Thiamine Hydrochloride instead of Thiamine Mononitrate.

The affected product is identified by NDC 48433-0108-01 and includes Lot numbers A15012, A15021, 16A004, 16A015, and 16A035. The product was distributed nationwide.

Consumers should check their medication boxes for the specific lot numbers listed above. If the product matches the description, consumers should stop using it and contact Safecor Health for a refund or replacement.

The recalled product

Product
Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA
Affected units
1,431

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Safecor Health Lot # A15012
  • A15021
  • 16A004
  • 16A015 and 16A035

Distribution

Distributed nationwide across the United States.

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