WASHINGTON (AP) - The Food and Drug Administration said Saturday it was 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, based in Fort Washington, Pa., issued the voluntary recall late Friday in the United States and 11 other countries after consulting with the FDA. The recall involves children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl, because they don't meet quality standards.
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 ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.
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.
Fact Box
Consumers wishing a product refund or product coupon can register online at www.mcneilproductrecall.com. Make sure to have all the bottles of medicine handy, as you will need to enter the NDC #, Lot # and expiration date of each.
The medicines were made and distributed in the United States, and exported to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait.
Details are available by telephone at 1-888-222-6036 or on the Web at www.mcneilproductrecall.com.
Below is the list of medicines recalled.
TYLENOL INFANTS' DROPS
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. GRAPE FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. GRAPE FLAVOR*
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. CHERRY DYE FREE
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. CHERRY FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. CHERRY FLAVOR
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. GRAPE - HOSPITAL
CONCENTRATED TYLENOL INFANTS' DROPS 0.25 OZ. GRAPE - SAMPLE
CHILDREN'S TYLENOL SUSPENSIONS
CHILDREN'S TYLENOL SUSPENSION 2 OZ. CHERRY BLAST FLAVOR
CHILDREN'S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR
CHILDREN'S TYLENOL DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR
CHILDREN'S TYLENOL SUSPENSION 4 OZ. GRAPE SPLASH
CHILDREN'S TYLENOL SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
CHILDREN'S TYLENOL SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR
CHILDREN'S TYLENOL SUSPENSION 1 OZ. CHERRY BLAST FLAVOR SAMPLE
CHILDREN'S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR HOSPITAL
CHILDREN'S TYLENOL PLUS SUSPENSIONS
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR
50580-386-04
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
MOTRIN INFANTS' DROPS
CONCENTRATED MOTRIN INFANTS' DROPS 1 OZ. BERRY DYE FREE
CONCENTRATED MOTRIN INFANTS' DROPS 0.5 OZ. BERRY DYE FREE
CONCENTRATED MOTRIN INFANTS' DROPS 0.5 OZ. BERRY FLAVOR*
CHILDREN'S MOTRIN SUSPENSIONS
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY DYE FREE
CHILDREN'S MOTRIN SUSPENSION 2 OZ. BERRY FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. GRAPE FLAVOR
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
CHILDREN'S MOTRIN SUSPENSION 1 OZ. GRAPE SAMPLE
CHILDREN'S MOTRIN SUSPENSION 1 OZ. BUBBLEGUM SAMPLE
CHILDREN'S MOTRIN SUSPENSION 1 OZ. BERRY SAMPLE
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY HOSPITAL
CHILDREN'S MOTRIN SUSPENSION 4 OZ. COLD BERRY FLAVOR
CHILDREN'S ZYRTEC LIQUIDS IN BOTTLES
CHILDREN'S ZYRTEC 4 OZ. BUBBLEGUM SYRUP
CHILDREN'S ZYRTEC DYE FREE 4 OZ. GRAPE SYRUP
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID
CHILDREN'S BENADRYL ALLERGY LIQUIDS IN BOTTLES
CHILDREN'S BENADRYL ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID
