I can't understand why you didn't provide a link. Here it is: http://www.fda.gov/bbs/topics/enforce/2002/ENF00775.html (scroll down to Drugs -- Class III, or do page search on Tylenol).
I wonder if the problem was that the dosing cup units were inconsistent with the instructions on the bottle or package. Obviously, if that's so, the correction should be to the instructions, not to the already metric dosing cup. That kind of inconsistency is mentioned in the article (dated October 1994) at http://www.fda.gov/fdac/reprints/drugdose.html. Here's the relevant paragraph: FDA Action Soon after FDA received the report of the acetaminophen dosing cup error, the agency learned of similar incidents with other acetaminophen drug products and pediatric cough/cold preparations. As a result, FDA undertook a survey of over-the-counter liquid medication makers to ensure that the labeling of these products is compatible with their dose cups and that the cups are easily readable. FDA's action prompted eight drug firms to recall nationwide over 980,000 bottles of oral medications and their accompanying dosage delivery devices because the devices were not consistent with the products' labeled directions. An earlier paragraph refers to an overdose resulting from instructions specifying teaspoons and a dosing cup calibrated in tablespoons. Obviously, the only safe answer is to enforce the use of SI throughout. Bill Potts, CMS Roseville, CA http://metric1.org [SI Navigator] >-----Original Message----- >From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED]]On >Behalf Of [EMAIL PROTECTED] >Sent: Thursday, February 20, 2003 12:19 >To: U.S. Metric Association >Subject: [USMA:24912] FDA recall metric rather than standard > > > 2003 February 20 >There is an FDA product recall listed in > Health Letter Jan 2003 I quote > > Children’s Tylenol (Acetaminophen) Oral Suspension > 160 mg, 4 Fl oz (120mL) bottles; Class III; > Defective container, product packaged with incorrect > dosing cups marked with metric measurements rather > than with U.S. Standard measurements > >It is on the FDA web. >Please help me by explaining why metric is not allowed. >Thanks. > Robert Bushnell PhD PE >
