Johnson and Johnson recall Tylenol voluntarily in 2009
September 29th, 2009 - 1:41 am ICT by Aishwarya Bhatt
New Brunswick, Sep 28 (THAINDIAN NEWS) Pharmaceutical company Johnson & Johnson has issued a complete voluntary recall of all its 80-milligram Children’s Tylenol Meltaways packaged in bottles and blisters, 80-milligram Children’s Tylenol SoftChews packaged in blisters, and 160-milligram Jr. Tylenol Meltaways packaged in blisters.
The company issued an advisory that the recall is due to the improper blister design as well as the incomplete information on the blister and bottle cartons which may be confusing and could lead to improper dosing, including over-dosing, in children.
In a letter dated Sept 18, 2009 and addressed to healthcare professional, Dr. Edwin K. Kuffner, vice president - Medical Affairs at McNell Consumer Healthcare says his company is voluntarily recalling certain lots of Children’s and infants’ Tylenol products that were manufactured between April 2008 and June 2008.
The trigger for the voluntary Tylenol recall is that the gram-negative bacteria Burkholderia cepacia (B. cepacia) was reportedly found in the raw material. However, the company specified that the portion of tainted raw material was not used in the production of any finished product. But as a precaution, McNell decided to recall all products that utilized any of the raw material at the same time the contamination was detected.
The company said that no bacteria have been found in the finished products and the finished product has met all specifications. And the FDA said no illness has been found associated with the recalled Tylenol products.
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