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Recall Observatory FDA recall evidence

Drug 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.

D-0669-2016

November 06, 2015

Class I

Product summary

Firm
Glades Drugs Inc.
Event
Event 72737
Status
Ongoing
Classification
Class I
Quantity
7800 capsules
Official record key
drug-enforcement:D-0669-2016

Official wording

Reason: Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).

Code information: 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, AICBCABF@4, AJADCABF@1, BAAICABF@1, BACCABF@3, AICECABF@1, AJBECABF@6, BABCCABF@2 and BBAECABF@5, Exp 02/20/2016

Distribution pattern: New York and Georgia

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent