McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait, because some of these products may not meet required quality standards. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use. Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch1.|
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.
The recalled products include the following:
TYLENOL® INFANTS’ DROPS
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR 50580-144-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* 50580-144-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE 50580-167-01
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR 50580-143-15
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR 50580-143-30
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE - HOSPITAL 50580-144-18
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE - SAMPLE 50580-144-40
CHILDREN’S TYLENOL® SUSPENSIONS
CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR 50580-123-02
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR 50580-123-04
CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR 50580-166-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH 50580-296-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-407-04
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR 50580-493-04
CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE 50580-123-01
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL 50580-123-03
CHILDREN’S TYLENOL® PLUS SUSPENSIONS
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR 50580-247-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR 50580-249-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR 50580-253-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR 50580-254-04
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-255-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR 50580-386-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR 50580-387-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR 50580-390-04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-391-04
MOTRIN® INFANTS’ DROPS
CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-01
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE 50580-198-15
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* 50580-100-15
CHILDREN’S MOTRIN® SUSPENSIONS
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE 50580-184-04
CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR 50580-601-02
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR 50580-601-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR 50580-215-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR 50580-603-04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-604-04
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE 50580-603-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE 50580-604-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE 50580-601-01
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL 50580-601-50
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04
CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES
CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP 50580-721-04
CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP 50580-730-04
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE 50580-730-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM 50580-721-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 50580-721-08
CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES
CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID
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On the recommendation of my vet and other dog care people, I purchased a bottle of bubblegum Benadryl in late April to give to my old arthritic dachshund to try to keep him calmer during a long car trip from Pittsburgh to Boston. The vet also said it was generally okay to give 10ml no more than three times per day so I also began giving one dose to him in the evening so he'd sleep better. It worked for the car ride and later for calming him down at night, (so we could get more sleep too).
ReplyDeleteWell I ended up having to put him to sleep a week ago because he started having seizures on top of his arthritis problems that started out minor but became so bad that he couldn't even stand up on his own let alone walk. Sadly, that was the critical evaluation point that I had decided upon many months ago talking it over with our vet and I stuck to it, (and that ain't easy).
So now, reading about this recall, is giving me second thoughts that I never imagined I'd ever encounter - the chance that maybe something was wrong with a drug he was getting that was responsible for a symptom that led me to conclude that it was time to put him down.
That really sucks and McNeil ought to at least know about wide variability the extent to which their mistakes can range. I threw out all of the dog's drugs including the benadryl so there's no way to know whether there was anything wrong with it or not. In a way I'm glad that I don't still have it because I know that the idea of having it tested would be haunting me right now.
I'm under no illusions here. My dog was nearing the end anyway and the prospect of facing having to put him to sleep had been discussed in the family for many weeks. Nonetheless, for me, this additional piece of information on the recall was most unwelcome and put doubt in my mind that I cannot erase.