The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0902-2017·Announced 2017-06-21

Safecor Health Recalls Calcium Carbonate and Vitamin D3 Tablets

Safecor Health is recalling 25 bottles of Calcium Carbonate and Vitamin D3 tablets due to CGMP deviations. The product was distributed in Massachusetts and New York.

The agency’s classification

FDA (Drugs): Class II

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.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which typically indicates a risk of temporary or medically reversible health consequences, fitting the Moderate severity criteria for voluntary precautionary recalls without reported injuries.

Plain-English summary

Safecor Health, LLC is voluntarily recalling 25 bottles of Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles. The recall was initiated by the firm and is classified as Class II by the FDA. The specific lot affected is # A18705, with an expiration date of 09/30/2017.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in Massachusetts and New York. The recall was initiated on July 7, 2016, and the firm notified customers via letter. The recall status is terminated as of July 12, 2017.

Consumers who have this product should stop using it and contact Safecor Health for further instructions. The recall number is D-0902-2017.

The recalled product

Product
Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
Manufacturer
Safecor Health, LLC
Category
Drug — Supplement
Hazard
Affected units
25

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 (2)

  • Lot # A18705
  • Exp. 09/30/2017

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 6 recalled by Safecor Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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