Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/py...

FDA Recall #D-0669-2016 — Class I — November 6, 2015

Recall #D-0669-2016 Date: November 6, 2015 Classification: Class I Status: Ongoing

Product Description

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.

Reason for Recall

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

Recalling Firm

Glades Drugs Inc. — Pahokee, FL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

7800 capsules

Distribution

New York and Georgia

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated