Johnson and Johnson Recall

On April 30, 2010, McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, announced a voluntarily recall of over fourty over-the-counter (OTC) Children’s and Infants’ medicine, including several versions of Tylenol, Motrin, Benadryl and Zyrtec from the United States, including its territories, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait.

According to the press release by McNeil Consumer Healthcare, the voluntary recall is "..not being undertaken on the basis of adverse medical events.". However, parents and caretakers are advised not to administer any of the listed products.

The recalled product may contain either too high a concentration of active ingredient , or may contain inactive ingredients, not meeting internal testing requirements. Some product may contain tiny particles. http://www.jnj.com/connect/news/all/McNeil-Consumer-Healthcare-announces-voluntary-recall-of-certain-OTC-infants-and-childrens-products

FDA Reports Deficiencies

On May 4, 2010, the Food and Drug Administration (FDA) released a preliminary inspection findings, which included several deficiencies, including a bacteria at the production plant in Fort Washington, Pennsylvania, where the recalled products were manufactured. No information was released of what type of bacteria was found, as Deborah Autor, director of the Office of Compliance, Center for Drug Evaluation and Research at the FDA, commented it was "too early" to give a positive identification.http://edition.cnn.com/2010/HEALTH/05/05/fda.mcneil.recall/

According to the FDA, deficient manufacturing practices at the plant may have been the cause for bacterial contamination of raw materials, which were used in the recalled products. Other manufacturing problems, included improper testing for contamination, and not initiating "corrective and prevention action" after receiving several dozens of consumer complaints in the period from June 2009 to April 2010 about foreign materials in the products. The FDA report is preliminary, and the FDA is still preparing a full report based on these findings. http://children.webmd.com/news/20100504/fda_manufacturing-problems-led-to-tylenol-recall

Deborah M. Autor of the FDA stated any actual risk by using the affected product "remote", but added that "consumers should not use these products -- and by all means, they should look for generic versions. Do not use products for infants or children that are not intended for their age groups."http://children.webmd.com/news/20100504/fda_manufacturing-problems-led-to-tylenol-recall

Full list of retracted products

Tylenol® Infant's ’ 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 50580-535-04

- CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.

- CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.

The Product NDC numbers are located on the label of the bottle above the brand name. http://www.jnj.com/connect/news/all/McNeil-Consumer-Healthcare-announces-voluntary-recall-of-certain-OTC-infants-and-childrens-products