Enforcement Report - Week of October 24, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | D-009-2013 |
| Classification | Class II |
| Code Info | Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012. |
| Product Distributed Qty | 161 gallons |
| 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. |
Event Detail
| Event Id | 63406 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Earthborn Products, Inc. |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-05 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide |
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