|
SGP recalls Claritin lots
|
 |
February 19, 2002: 1:38 p.m. ET
Schering-Plough recalls lots of Claritin-D, but says there's no health risk.
|
NEW YORK (CNN/Money) - Schering-Plough said Tuesday it is recalling certain lots of allergy treatment Claritin-D from retailers and wholesalers after quality-control tests showed a delayed release of the decongestant ingredient.
Schering-Plough (SGP: down $0.77 to $34.24, Research, Estimates) is recalling specific lots of Claritin-D 12-hour manufactured between August 1999 and June 2001, but the company stressed that the tablets pose no safety risk and said it is not recalling them from patients.
After administering quality-control tests on the 12-hour Claritin-D pills, the company found that the decongestant pseudoephedrine did not demonstrate full release after five hours, although it did 25 minutes later.
The company said it "believes that this short delay in achieving full release of pseudoephedrine would have no clinical consequence on expected efficacy or safety of these products, and that there is no medical risk to patients."
Schering-Plough also said it believes most of the inventory subject to the recall is depleted and the action will not affect 2002 earnings guidance.
The company has been plagued by quality-control problems and in December warned it may have to pay up to $500 million to regulators to settle problems at its New Jersey and Puerto Rico plants.
Also on Tuesday, the Federal Trade Commission said it settled charges with American Home Products Corp. that the company Schering-Plough entered into an anticompetitive agreement to delay the market entry of a generic drug.
The FTC alleged Schering-Plough paid AHP "millions of dollars" to delay AHP's generic version of a Schering-Plough potassium chloride supplement.
The settlement prohibits AHP (AHP: down $0.02 to $63.13, Research, Estimates) from entering into several types of potentially anticompetitive agreements and requires the company to notify the FTC before entering into other types of agreements.
The types of agreements prohibited include one "in which a brand-name company makes payments to generic entrant and the generic aggress not to market its product for some period of time," except in certain limited circumstances, and agreements "between the brand-name company and a generic entrant in which the generic agrees not to enter the market with a generic product that is not subject to a claim of patent infringement." 
|
|
|
|
|
|
|
