August 31, 1999
Recall of Tubex® Epinephrine Used
in Allergic Reaction Kits Updated
ST. DAVIDS, PA (SafetyAlerts) - Wyeth-Ayerst Laboratories, a division of
American Home Products Corporation is voluntarily recalling specific lots of Epinephrine
Injection, USP 1:1000 in 1 mL Tubex® syringe, used in emergency allergy kits.
Samples taken in routine quality-control tests were found to be discolored and sub-potent,
which could pose a potential health hazard for those with known allergies to insect stings
or certain foods
Derm/Buro Insect-Sting Treatment Kits
with the following lot numbers, found on the front label of the kit, should be returned to
the hospital, clinic or pharmacy where they were obtained: 0397, 0497, 0597, 8141, 8139,
11464, 13239. These products were distributed between June 1997 through February 1999.
Ana-Kits with lot numbers AK344
through AK363 and lot AK366, and Ana-Guard with lot numbers G00196
through G00220, and lots G00222 and G00223 should also be returned to the hospital, clinic
or pharmacy where they were obtained. Ana-Kit lot numbers are located on the front label
of the kit, and Ana-Guard lot numbers can be found on the top panel of the box. These
products were distributed by Bayer Corporation between April 1997 and April 1998.
The recalled kits were distributed to hospitals,
pharmacies, physicians and consumers nationwide. "We encourage those who depend on
these kits to err on the side of caution," said Philip de Vane, MD, Vice President,
Clinical Affairs and North American Medical Director. "Contact your pharmacist or
other healthcare provider if you are not sure whether your kit is being recalled or has
Wyeth-Ayerst Laboratories is a major
research-oriented pharmaceutical company with leading products in the areas of women's
health care, cardiovascular disease therapies, central nervous system drugs, anti-
inflammatory agents, vaccines, and generic pharmaceuticals.
American Home Products is one of the world's
largest research-based pharmaceutical and health care products companies. It is a leader
in the discovery, development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It also is a global leader in vaccines, biotechnology,
agricultural products, and animal health care.
Only these specific lots of the product are
affected by this recall. Consumers are encouraged to consult their pharmacist or physician
to discuss whether a replacement product is needed. Consumers can also call Wyeth-Ayerst
Laboratories at 1-800-999-9384. Replacement products are available through physician
offices or pharmacies.
Safety Alerts compiles comprehensive safety
recall information for the United States. SafeMail is a free email service to warn
consumers of faulty products and contaminated foods. For complete information regarding
current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.
# # #