Columbia-based Meridian Medical Technologies Inc. yesterday launched an urgent nationwide recall of an estimated 1 million of its spring-activated automatic injectors for treating severe allergic reactions and asthma attacks.
The company said it was recalling the popular auto-injectors EpiPen and EpiPen Jr. because some of the pens may not provide sufficient doses of epinephrine, the medication loaded in the injectors.
People with severe allergies to certain foods, bee stings or insect venom as well as asthmatics carry the injectors to ward off life-threatening reactions.
"We are well aware of the seriousness of this," said James D. Miller, president and chief executive officer of Meridian. "We will move heaven and earth to ensure this never happens again."
The company said it does not know of any patient who has been hurt by ineffective injectors. The defect was discovered during a routine inspection of the injectors, Miller said.
Anne Munoz-Furlong, founder of the Food Allergy Network, a Fairfax-Va.-based group, praised Meridian for acting aggressively and quickly.
"This is what patients want from these companies. No one minds making an extra trip to the pharmacy if it's going to protect their life," she said.
The group planned to post recalled lot numbers and other information about the recall on its Web site, www.foodallergy.org.
Baer Laboratories Inc. is Meridian's only competitor in the allergy market. It markets a filled syringe and needle product.
Miller said Meridian had determined that a production glitch in a new automated system was responsible for underfilling the injectors. He said the company had switched back to its old production system until it could correct the problem.
Most of the recalled lots of Meridian's EpiPen and EpiPen Jr. were distributed in the United States; others were sent to Germany, Israel, Denmark, Canada, Turkey, Australia, Greece and South Africa, the company said.
The affected products were distributed in the United States by Dey Laboratories between July 1997 and April 1998 and are identified on the packaging as being manufactured for Center Laboratories or Dey Laboratories by Survival Technology Inc. or Meridian Medical Technologies.
The company is offering free replacements for pens in recalled lots. For further information, patients may call 1-800-240-5788.
Miller estimated that 10 percent of the recalled pens are &L; defective and said the company planned to inspect returned devices. Those that operate will be returned to the sales stream.
The company said it would hold $2.2 million in reserve for paying for the recall as a possible charge against its third-quarter earnings.
As a result of that and a debt refinancing charge, the company said, a third-quarter loss of $1.1 million, or 35 cents per share, is anticipated for the quarter that ended March 31.
Yesterday, the company said preliminary earnings for the quarter without the recall and debt refinancing charges, increased 22 percent to an anticipated $721,000, or 22 cents a share. Meridian said revenue rose to $13.1 million in the quarter.
Pub Date: 5/09/98