Here's a press release that may be of interest since some of you may use
this product for your rabbits:
FORT WASHINGTON, Pa., Nov 10, 2008 /PRNewswire via COMTEX/ -- Johnson &
Johnson-Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily
recalling approximately 12,000 units of Infants' MYLICON(R) 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(R) 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(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.
71683791111-1 SMF008 09/10 Infants' Mylicon(R) 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(R) 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
http://www.mylicon.com for
instructions regarding how to dispose of the product and request a
replacement or refund.
Infants' MYLICON(R) 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(R) GAS RELIEF
products (1/2 oz. or 1 oz. size) or Infants' MYLICON(R) 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:
http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
Fax: 1-800-FDA-0178
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