Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-009-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 5, 2012
- FDA report date
- Oct 24, 2012
- Quantity
- 161 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Earthborn Products, Inc.
Original FDA data
Every field from FDA enforcement report D-009-2013, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63406
- Address
- 9275 Sky Park Ct Ste 101
- Code information
- Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.
- Postal code
- 92123-4386
- Report date
- Oct 24, 2012
- Product type
- Drugs
- Recall number
- D-009-2013
- Classification
- Class II
- Recalling firm
- Earthborn Products, Inc.
- Product quantity
- 161 gallons
- Termination date
- Feb 28, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 5, 2012
- Initial firm notification
- Center classification date
- Oct 18, 2012