Schering-Plough Corporation (NYSE: SGP) today announced a voluntary recall directed to wholesale accounts and retail pharmacies of specific lots of CLARITIN-D(R) 12 Hour (5 mg loratadine/120 mg pseudoephedrine sulfate, USP) Extended Release Tablets that are still within their labeled expiration date. These products were manufactured between August 1999 and June 2001. This recall does not extend to the patient level as the company believes these products are clinically safe and effective, and pose no medical risk to patients. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Schering-Plough as part of its standard quality-control procedures conducted stability testing of specific lots of CLARITIN-D 12 Hour Tablets, including dissolution tests to determine the rate that tablets dissolve and the amount of active ingredients released. Results of these tests indicated that some tablets in these lots did not demonstrate full release of pseudoephedrine (the decongestant ingredient) at the fifth hour per specification, although by 25 minutes later all tested samples met specifications for releasing pseudoephedrine. The company 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. The company reported the dissolution test results to the FDA, and this issue was subsequently cited in an FDA inspection report (Form FDA 483) dated Feb. 8, 2002.
Schering-Plough believes that most of the trade inventory subject to this recall has been depleted. The company is manufacturing CLARITIN-D 12 Hour Tablets and recently has begun shipping new product to the trade. CLARITIN-D 12 Hour is an antihistamine/decongestant combination product indicated for the relief of symptoms of seasonal allergic rhinitis.
Individual units of CLARITIN-D 12 Hour Tablets are marked with a lot number that includes a prefix number representing the year of manufacture. Any lot with a prefix number of "0" or "1" (representing the years 2000 and 2001), respectively, is included in this recall. In addition, lots 9-JRP-313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042, which were manufactured in 1999, are also included in this recall. Any lot bearing a prefix number of 2 (representing 2002) is not included in this recall.
Only CLARITIN-D 12 Hour Tablets with the indicated lot numbers are subject to this recall. Patients who may have CLARITIN-D 12 Hour Tablets do not need to return these products to their pharmacies or to Schering-Plough. This recall does not affect any other product formulation in the CLARITIN(R) (loratadine) family of nonsedating antihistamines.
Schering-Plough emphasized that this recall of specific lots of CLARITIN-D 12 Hour Tablets will not affect the company's previously announced earnings guidance for 2002, as stated in press releases issued on Dec. 21, 2001, and Jan. 24, 2002.
Any questions regarding this recall should be directed to the CLARITIN-D Information Center at 1-866-300-1516. Anyone who should become aware of any adverse events associated with the product subject to this recall should contact the CLARITIN-D Information Center or the FDA MEDWATCH program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail to MEDWATCH, HF-2, 5600 Fishers Lane, Rockville, MD, 20857.
DISCLOSURE NOTICE: In addition to historical information, this press release includes certain "forward-looking" information relating to the company's projected earnings for 2002, and the U.S. market availability of CLARITIN-D 12 Hour Tablets. The reader of this release should understand that the extent that CLARITIN products will be prescribed will be determined by market forces. In addition, the risks and uncertainties relating to the company's 2002 earnings projection are described in detail in the company's Dec. 21, 2001, and Jan. 24, 2002, press releases, which are available on the company's Web site at www.schering-plough.com. In addition, the forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, current and future branded, generic or OTC competition, federal and state regulations and legislation, the regulatory process for new products and indications, existing and new manufacturing issues that may arise, trade buying patterns, exchange rate fluctuations, patent positions, litigation and investigations. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2000 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.
Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.