Wednesday, May 5, 2010

May 2010: J&J Recall of Children's and Infants OTC Products; FDA Follow-up Criticizes Factory Conditions

Johnson and Johnson voluntarily recalled 1,500 various lots of over the counter liquid medicines including Tylenol, Motrin and Benadryl, intended for infants and children on April 30, 2010. There are a slew of issues concerning the recalled products including some containing a higher content of active ingredients than noted on the label, some containing possibly harmful particles, and some with inactive ingredients that may be harmful as well.& While the issues found with the recalled products have minimal chance of causing serious health effects, they do not meet internal testing requirements and should not have been put on the shelves for consumers.

An FDA inspection report conducted in late April found multiple quality assurance concerns with the Fort Washington, PA plant and the FDA is now considering criminal charges. The report showed evidence of Johnson and Johnson's acceptance of raw materials from vendors that were infected with an unidentified bacteria. Johnson and Johnson is temporarily ceasing production at the plant, claiming that they have the best interest of their customers in mind at all times. Johnson and Johnson has held high reputation for integrity among its customers when most remember the 31 million bottle recall of Tylenol back in 1982, after 7 deaths were related to Cyanide-laced pills

2010 List of Johnson and Johnson Recalled Childrens' and Infants' Products:
  • Concentrated Tylenol Infant Drops, Grape Flavor (1.0 oz and 0.5 oz)
  • Concentrated Tylenol Infant Drops, Cherry Dye Free (1.0 oz)
  • Concentrated Tylenol Infant Drops, Cherry Flavor (1.0 oz and 0.5 oz)
  • Concentrated Tylenol Infant Drops, Grape Flavor; hospital (0.5 oz)
  • Concentrated Tylenol Infant Drops, Grape Flavor; sample (0.25 oz)
  • Childrens' Tylenol Suspension, Cherry Blast Flavor (1.0 oz sample, 2.0 oz and 4.0 oz)
  • Childrens' Tylenol Dye-Free Suspension, Cherry Flavor (4.0 oz)
  • Childrens' Tylenol Suspension, Grape Splash Flavor (4.0 oz)
  • Childrens' Tylenol Suspension, Bubblegum Flavor (4.0 oz)
  • Childrens' Tylenol Suspension, Very Berry Strawberry Flavor (4.0 oz)
  • Childrens' Tylenol Suspension, Cherry Blast Flavor; hospital (4.0 oz)
  • Childrens' Tylenol Plus Suspension, Cough and Sore Throat Cherry Flavor (4.0 oz)
  • Childrens' Tylenol Plus Suspension, Cough and Runny Nose Cherry Flavor (4.0 oz)
  • Childrens' Tylenol Plus Dye Free Suspension, Cough and Stuffy Nose Grape Flavor (4.0 oz)
  • Childrens' Tylenol Plus Dye Free Suspension, Cold and Cough Grape Flavor (4.0 oz)
  • Childrens' Tylenol Plus Dye Free Suspension, Multi-Symptom Cold Grape Flavor (4.0 oz)
  • Childrens' Tylenol Plus Suspension, Flue Bubblegum Flavor (4.0 oz)
  • Childrens' Tylenol Plus Suspension, Cold Grape Flavor (4.0 oz)
  • Childrens' Tylenol Plus Suspension, Cold and Allergy Bubblegum Flavor (4.0 oz)
  • Childrens' Tylenol Plus Suspension, Multi-Symptom Cold Grape Flavor (4.0 oz)
  • Concentrated Motrin Infants' Drops, Berry Dye Free (1.0 oz and 0.5 oz)
  • Concentrated Motrin Infants' Drops, Berry Flavor (0.5 oz)
  • Childrens' Motrin Suspension, Berry Dye Free (4.0 oz)
  • Childrens' Motrin Suspension, Berry Flavor (2.0 oz)
  • Childrens' Motrin Suspension, Berry Flavor (4.0 oz)
  • Childrens' Motrin Suspension, Tropical Punch Flavor (4.0 oz)
  • Childrens' Motrin Suspension, Grape Flavor (4.0 oz)
  • Childrens' Motrin Suspension, Bubblegum Flavor (4.0 oz)
  • Childrens' Motrin Suspension, Grape Flavor; sample (1.0 oz)
  • Childrens' Motrin Suspension, Bubblegum Flavor; sample (1.0 oz)
  • Childrens' Motrin Suspension, Berry Flavor; sample (1.0 oz) 
  • Childrens' Motrin Suspension, Berry Flavor; Hospital (4.0 oz)
  • Childrens' Motrin Suspension, Cold Berry Flavor (4.0 oz)
  • Childrens' Zyrtec, Bubblegum Flavor (4.0 oz)
  • Childrens' Zyrtec, Dye Free Grape Syrup (4.0 oz)
  • Childrens' Zyrtec, Sugar Free Dye Free Grape (0.5 oz)
  • Childrens' Zyrtec, Sugar Free Dye Free Bubblegum (0.5 oz)
  • Childrens' Zyrtec, Sugar Free Dye Free Bubblegum Liquid (2X4 oz)
  • Childrens' Benadryl Allergy Liquid in Bottles
  • Childrens' Benadryl Allergy Liquid, Bubblegum Flavor (4.0 oz)
  • Concentrated Tylenol Infants' Drops, Grape Flavor (0.5 oz and also included in Johnson's Baby Relief Kit
  • Concentrated Tylenol Infants' Drops, Bubblegum Flavored Liquid (0.5 oz and also included in Johnson's Baby Relief Kit
 More information on this article can be found at Johnson and Johnson's Corporate Website.
 

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