February 20, 2002Schering-Plough Has Recalled
Kenilworth, NJ (SafetyAlerts)
- Schering-Plough Corp. is recalling batches of its best-selling allergy
drug Claritin from stores and wholesalers because a decongestant ingredient
does not dissolve fast enough, but says patients with the drug do not need
to return it.
The company issued a voluntary recall Tuesday of certain lots of Claritin-D
12-hour extended release tablets manufactured between August 1999 and June
2001 because some tablets did not release enough pseudoephedrine within five
The company said adequate levels of pseudoephedrine were released about 25
minutes later than called for under its specifications. It said the delay
does not hurt the drug's effectiveness, and said there is no medical risk in
Company spokesman Robert Consalvo said federal regulations require drug
manufacturers to meet certain specifications in order to sell a particular
drug. Because of the problem Schering-Plough found with the Claritin lots,
it had to recall the product from stores.
Consumers who received prescriptions from pharmacies would not know which
lots their pills came from, he said. Because of this, and the company's
belief that the drugs are still safe and effective, the recall was not
extended to the patient level, he said.
Consalvo said it believes most of the affected lots have already been sold
or used by patients. He said the recall involved 97 lots, but would not say
how many pills that constituted, saying that figure is proprietary
Affected lots carry a prefix number of "0" or "1" (representing the years
2000 and 2001). Five additional lots, numbered 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 the recall.
The company has begun manufacturing and shipping new batches of Claritin to
Claritin is the company's top-selling product, bringing in $3.1 billion in
2001. But the drug's basic patent expires at the end of this year, and
competitors are already seeking permission to sell over-the-counter