Chart: FDA Recalls & Court Actions

FDA Recalls & Court Actions

Jan. 15, 2003

CLASS III - UPDATE
Children's Tylenol (Acetaminophen) Oral Suspension
160 mg, 4 fl. oz. (120 mL) bottles. (a) Bubblegum flavor, NDC No. 50580-407-04. Lot No. EFM041, exp. 7/03; (b) Grape flavor, NDC No. 50580-296-04. Lot No. EFM040, exp. 7/03. [Editor's note: This recall appeared in "The Tan Sheet" Jan. 6, 2003, p. 12. The expiration dates for lots EFM041 and EFM040 have been updated as shown by FDA.]
Manufacturer:	McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA.
Recalled by:	Manufacturer, by letter on Nov. 20, 2002. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 116,172 bottles.
Reason:	Defective container; product packaged with incorrect dosing cups marked with metric measurements rather than with U.S. standard measurements.
Recall numbers:	D-096/097-3.
EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Tan Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation.