Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl...
FDA Recall #D-009-2013 — Class II — October 5, 2012
Product Description
Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
Reason for Recall
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Recalling Firm
Earthborn Products, Inc. — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
161 gallons
Distribution
Nationwide
Code Information
Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated