The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0669-2016·Announced 2016-02-24

Glades Drugs Recalls Vitamin D3 Supplement Due to Excessive Potency

Glades Drugs Inc. is recalling Vitamin D3 supplement capsules because they contain an extremely high level of vitamin D3.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Glades Drugs Inc. is recalling Vitamin Supplement (Vial) D3 capsules, which contain cholecalciferol (vitamin D3), lipoic acid, ubiquinol, methylcobalamin, pyridoxine, methionine, inositol, and choline bitartrate USP. The recall involves 60, 120, or 180 count vials. The total quantity affected is 7,800 capsules.

The FDA has classified this as a Class I recall because the product is a superpotent drug, meaning it contains an extremely high level of vitamin D3. This excessive potency poses a significant risk of adverse health consequences to consumers.

The affected products were distributed in New York and Georgia. Consumers should stop using the recalled capsules and check their lot codes against the list provided by the FDA, which includes codes such as AICACABF@3 and AICECABF@2, with an expiration date of 02/20/2016.

The recalled product

Product
Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.
Manufacturer
Glades Drugs Inc.
Affected units
7,800

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 (20)

  • AICACABF@3
  • AICECABF@2
  • AJBFCABF@4
  • ABCCABF@4
  • AICACABF@5
  • AICECABF@3
  • AJBHCABF@2
  • ABCCABF@5
  • AICBCABF@1
  • AICECABF@4
  • AJCBCABF@1
  • ABGCABF@4
  • AICBCABF@2
  • AICECABF@5
  • JCBCABF@2
  • BACDCABF@5
  • AICBCABF@3
  • AICICABF@3
  • BAAGCABF@2
  • BADACABF@3

Distribution

Distributed in 2 states:

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