Chart: FDA Recalls & Court Actions

FDA Recalls & Court Actions		July 21, 2004
CLASS III
Aspirin, Enteric Coated Tablets
81 mg, 120-count bottles, Adult Low Strength Pain Reliever, Brooks brand. Also sold under the following brand names: Good Sense brand, Perrigo, NDC 0113-0535-76; Longs brand, NDC 12333-9537-1; Perfect Choice brand, NDC 41226-535-76; Safeway brand, NDC 21130-535-76; Shop Rite brand; Equate brand, NDC 0113-1535-76; Food Lion brand, NDC 55316-535-76; Brite-Life brand, NDC 24385-535-76; Good Neighbor Pharmacy brand, distributed by Bergen Brunswig Drug, NDC 24385-535-76; Valu-Rite brand, NDC 49348-756-53; Family Pharmacy brand, NDC 52735-761-23; and Leader brand. Lot numbers 2DE0148 and 2DE0584; EXP. 01/05.
Manufacturer:	Perrigo Co., Allegan, MI.
Recalled by:	Manufacturer, by letter dated June 25, 2004. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 99,252 bottles.
Reason:	Dissolution failure; enteric coating.
Recall number:	D-215-4.
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.