Peninsula Daily News News Services
WASHINGTON—The U.S. Food and Drug Administration said it is investigating a health-care company for possible other problems following its recall of more than 40 over-the-counter infant’s and children’s liquid medications.
McNeil Consumer Healthcare, a division of Johnson & Johnson based in Fort Washington, Pa., issued the voluntary recall late Friday in the United States, Canada and 10 other countries after consulting with the FDA.
The recall involves children’s versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl in 43 different flavors and sizes because they don’t meet quality standards.
The products include Tylenol Infants’ Drops, Children’s Tylenol Suspensions, Infants’ Motrin Drops, Children’s Zyrtec liquids in bottles and Children’s Benadryl Allergy liquids.
McNeil has posted a full list of the recalled product lots on a dedicated Web site, mcneilproductrecall.com, or consumers can call a hotline, 888-222-6036.
The FDA called the potential for serious medical problems “remote,” but it advised consumers to stop using the medicine as a precaution.
It said a health-care professional should be consulted if a child has recently taken any of the recalled products and is exhibiting unexpected symptoms.
The FDA also says parents in the interim should consider substitute child medications, such as generic versions.
It does not recommend that children be given adult-strength Tylenol or Motrin because they are not intended for younger age groups.
The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems.
“We are following through with the facility to make certain that everything has been checked,” said FDA spokeswoman Elaine Gansz Bobo.
According to McNeil and the FDA, some of the products recalled may have a higher concentration of active drug ingredient than is specified on the bottle, or may contain foreign particles or ingredients that may not meet testing requirements.
The medicines were made and distributed in the United States, and exported to Canada, the Dominican Republic, the United Arab Emirates, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait.
