Chart: FDA Recalls & Court Actions

FDA Recalls & Court Actions

Dec. 5, 2001

CLASS II
Equate Allergy Medication Decongestant Caplets
In 24 caplet blister cartons. The product is an OTC product containing Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg, capsule-shaped tablets. Lot No. 1GB0825, 1GB1041, 1GB1042.
Manufacturer:	Leiner Health Products, Inc. Carson, CA.
Recalled by:	Leiner Health Products, Inc. Fort Mill, SC. Firm initiated recall is ongoing.
Distribution:	Nationwide; 45,504/24 caplet cartons.
Reason:	Misbranding; directions for use may lead to a doubling of the dosage.
Recall number:	D-040-2.
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.