[U.S. Food and
Drug  Administration]

This is the retyped text of a press release from Meridian Medical Technologies Inc. Contact the company with any questions.


Meridian Medical Technologies

Contacts:

Lori McGahren-Clemens
Ogilvy Public Relations
212-880-5346

Thomas Handel
Meridian Medical
410-309-6830


IMMEDIATE RELEASE

MERIDIAN ANNOUNCES NATIONWIDE VOLUNTARY CLASS I RECALL OF EPIPEN AND EPIPEN JR. AUTO-INJECTORS

COLUMBIA, MD, May 08, 1998 -- Meridian Medical Technologies Inc. (NASDAQ:MTEC) today announced that it is conducting a voluntary Class I recall of 47 lots of EpiPen and EpiPen Jr. auto-injectors distributed in the United States, Germany, Israel, Denmark, Canada, Turkey, Australia, Greece and South Africa. Meridian is recalling these products because some of these may not provide effective doses of medication to treat acute allergic emergencies (anaphylaxis). Patients who have product with the involved lot numbers should return them to their place of purchase for a free replacement. If a replacement is not available, patients should contact their health care provider. For further information, patients may call 1-800-240-5788.

The affected product was distributed in the United States by Dey Laboratories between July 1997 and April 1998 and is identified on the packaging as being manufactured for Center Laboratories or Dey Laboratories by Survival Technology Inc. or Meridian Medical Technologies. The EpiPen and EpiPen Jr. lot numbers are imprinted on both the end of the outside of the carton and on the auto-injector label (in the clear area).

Lot numbers involved are:

7SX208, 7SX209, 7SX216, 7SX217, 7SX194
7RX204, 7RX223
7SR247, 7SR265, 7SR286, 7SR292, 7SR293, 7SR317, 7SR318, 7SR321, 7SR342, 7SR355, 7SR356, 7SR358, 7SR370, 7SR371, 7SR378
7JR242, 7JR243, 7JR289, 7JR290, 7JR323, 7JR361, 7JR362, 7JR374, 7JR375
8SR004
8SS077, 8SS078
7C6214, 7C6279, 7C8277, 7C8381, 7F7221, 7F7262, 7F7380
7C5238, 7C5376, 7F8391, 7F8220, 7F8263, 7CA382

All other lot numbers are safe to use.

"We have identified and addressed the cause of the problem. We are confident it is isolated to these lots. The problem arose in the process of advancing our automated production capabilities. Thus, we have returned to our original and unaffected production method," stated James H. Miller, chairman, president and chief executive officer of Meridian. "While no patient has been affected, our ultimate responsibility is to protect those patients who depend on the life-saving capability of the EpiPen auto-injector. That is our number one priority, as it has been in the over 17 years that we have been manufacturing EpiPen and EpiPen Jr. products."

Meridian has manufactured approximately 150 million auto-injectors in the history of the company and has produced EpiPen and EpiPen Jr. for more than 17 years. Meridian Medical Technologies is a worldwide leader in the development of auto-injector drug delivery systems. The company also develops and manufactures emerging products for the cardiopulmonary care market. Meridian Medical Technologies provides technology solutions for medicine in early intervention home health care and emergency medical technologies. Additional company information is available on the World Wide Web at www.meridianmeds.com.

###


Return to Summary


Return to MedWatch
Home Page Your Comments Please Return to Safety Issues
Page

[FDA Home Page]