The paint on the children’s wooden beads contains excessive levels of lead, violating the federal lead paint standard.
Posts Tagged ‘Amp’
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Painted Wooden Beads Intended for Children's Crafts Recalled By S&S Worldwide Due To Violation of Lead Paint Standard
by MommySite
Category Recalls | Tags: Amp,Children Crafts,Excessive Levels,Lead Paint,Paint Standard,Wooden Beads | No Comments
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Infant Mylicon Recall for Metal Fragments
by MommySite Mom
This is old, but in case you have a bottle around the house, it’s worth checking the lot number.
JOHNSON & JOHNSON • MERCK CONSUMER PHARMACEUTICALS COMPANY ANNOUNCES URGENT VOLUNTARY NATIONWIDE RECALL OF INFANTS’ MYLICON® 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’ 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 20852-9787Fax: 1-800-FDA-0178
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Category Recalls | Tags: Amp,Consultation,Consumers,Fda,Food And Drug,Food And Drug Administration,Food And Drug Administration Fda,Gas Relief,Health,Health care,Health Care Provider,Johnson & Johnson,Manufacturing Process,Medical Events,Medical Treatment,Medicine,MedWatch,Merck,Metal Fragments,Mylicon,MYLICON Gas Relief Dye Free,mylicon. infant,Parents,Pharmaceuticals Company,Plastic Bottles,Precaution,recall. gas drops,Simethicone,U.S. Food and Drug Administration,United States | No Comments
