Two lots of the popular infant gas drops, Mylicon, were recalled by the manufacturer due to potential contamination with metal fragments. There are no details on the true health hazard--and there are no reported problems thus far. But, no one really wants their gassy baby to be eating metal. Here's the actual press release from the FDA:
FOR IMMEDIATE RELEASE -- Fort Washington, PA (November 7,
2008) – Johnson & Johnson • Merck Consumer Pharmaceuticals
Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS
RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic
bottles that were distributed after October 5, 2008 nationwide. The
company is taking this action in consultation with the U.S. Food and Drug Administration
(FDA). Although the potential for serious medical events is low, the company
is implementing this recall to the consumer level as a precaution after determining
that some bottles could include metal fragments that were generated during
the manufacturing process. If any medical events were to occur,
most are expected to be temporary and resolve without medical treatment. Parents
who have given the product to their infant and are concerned should contact
their health care provider immediately.
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. |
Consumers can find the lot numbers on the bottom of the box containing the
product and also on the lower left side of the sticker on the product bottle.
Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops
non-staining included in this recall should immediately stop using the product
and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00
p.m. EST) or via the internet at www.mylicon.com for
instructions regarding how to dispose of the product and request a replacement
or refund.
Infants' MYLICON® drops are sold
over-the counter, in retail stores and pharmacies, as an anti-gas medicine
to relieve the discomfort of infant gas frequently caused by air swallowing
or by certain formulas or foods.
The recall does not affect any 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).
The manufacturer has instructed retailers and wholesalers to return their
inventories.
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
Two lots of the popular infant gas drops, Mylicon, were recalled by the manufacturer due to potential contamination with metal fragments. There are no details on the true health hazard--and there are no reported problems thus far. But, no one really wants their gassy baby to be eating metal. Here's the actual press release from the FDA:
FOR IMMEDIATE RELEASE -- Fort Washington, PA (November 7, 2008) – Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.
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.
Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.
Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.
Infants' MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.
The recall does not affect any 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).
The manufacturer has instructed retailers and wholesalers to return their inventories.
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