Home / Recalls / Earthborn Products, Inc. / D-009-2013

D-009-2013 Class II Terminated

Recalled by Earthborn Products, Inc. — San Diego, CA

Recall Details

Product Type: Drugs
Report Date: October 24, 2012
Initiation Date: October 5, 2012
Termination Date: February 28, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 161 gallons

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.

Distribution Pattern

Nationwide

Code Information

Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.