The FDA has announced an urgent recall of around 12,000 units of Infants’ MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles, that were distributed nationwide after October 5, 2008.
This recall has been issued as a precaution, because it was determined that some bottles could contain metal fragments, which got into the products during the manufacturing process.
According to the FDA’s official press release, any ill effects caused by consuming affected products should be “temporary and resolved without medical treatment” – nevertheless, you are advised to contact your health care provider if you have given the product to your baby and are in any way concerned about their health.
The two lots of Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:
| Product Code # |
Lot # | Exp | Product |
|---|---|---|---|
| 71683791111-1 | SMF007 | 09/10 | Infants’ Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz. |
| 71683791111-1 | SMF008 | 09/10 | Infants’ Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz. |
You can find the lot numbers on the bottom of the product’s box and also on the lower left side of the sticker on the product bottle. If you do have this product at home, the FDA advises that you should stop using it straight away and contact the company to receive instructions for disposing of the product and arranging for a replacement or a refund.
You can contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or online at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.
No Original Infants’ MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size) are included in this recall.
From the FDA’s press release…
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm
Regular Mail: Use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178