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Date: | Thu, 13 Nov 2008 10:22:41 -0800 |
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"The recall does not affect any Original Infants' MYLICONŽ GAS RELIEF
products (1/2 oz. or 1 oz. size) or Infants' MYLICONŽ GAS RELIEF DYE FREE
drops non-staining (1/2 oz. size). "
JOHNSON & JOHNSON . MERCK CONSUMER PHARMACEUTICALS COMPANY ANNOUNCES URGENT
VOLUNTARY NATIONWIDE RECALL OF INFANTS' MYLICONŽ GAS RELIEF DYE FREE DROPS
(SIMETHICONE-ANTIGAS) NON-STAINING DUE TO POSSIBLE METAL FRAGMENTS
Fort Washington, PA (November 10, 2008) - Johnson & Johnson . Merck Consumer
Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately
12,000 units of Infants' MYLICONŽ 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' MYLICONŽ 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' MYLICONŽ Gas Relief Dye Free Non-Staining Drops 1 oz.
71683791111-1
SMF008
09/10
Infants' MYLICONŽ 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' MYLICONŽ 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' MYLICONŽ 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' MYLICONŽ GAS RELIEF
products (1/2 oz. or 1 oz. size) or Infants' MYLICONŽ 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.
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