For American Home, which faces legal problems from its diet drugs and Norplant contraceptive device, the recall is just the company's latest setback.
American Home's Wyeth-Ayerst Laboratories division said it is voluntarily recalling Epinephrine Injection, USP1:1000 in 1 mL Tubex syringe. The company said it's taking the action after observing discolored samples in routine quality-control tests. A few of the discolored samples were found to be less potent than they should be, which could pose a potential health hazard for those who use them to battle the allergic reactions.
"We encourage those who depend on these kits to err on the side of caution," Philip de Vane, North American medical director for Wyeth-Ayerst, said in a statement. He encouraged consumers to contact their pharmacists and other health care providers to determine whether their allergy kits are being recalled or have lost potency.
The recall includes the Insect-Sting Treatment Kit packaged and distributed by Derm/Buro Inc.; Anaphylaxis Emergency Treatment Kit packaged and distributed by Bayer Corp. as Hollister Stier -Ana-Kit; and Ana-Guard, which was packaged and distributed by Bayer.
About 450,000 Ana-Kits and 55,000 Ana-Guards are being recalled in the United States and Canada, said Kathleen Bauernschmidt, spokeswoman for Hollister-Stier Laboratories of Spokane, Wash. Bayer sold its allergy kit manufacturing business to Hollister-Stier in June.
It was unclear how many kits were being recalled by Derm/Buro.
The number of kits being recalled represents about 25 percent of all allergic reaction kits on the market, Bauernschmidt said.
Consumers can call Wyeth-Ayerst at 1-800-999-9384. Replacement products are available through doctors' offices and pharmacies.
In August, a jury awarded $23 million to a Texas woman who claimed the company failed to warn her about the dangers of its diet drugs, Redux and Pondimin, also called fen-phen. Hundreds of lawsuits are now pending nationwide against the company stemming from the diet pills potential to cause heart-valve problems.
The company this summer suspended shipments of rotavirus after it was linked to bowel obstruction in 32 infants. And last year, American Home recalled a painkiller Duract after it caused fatal liver problems.
With the latest recall, Derm/Buro Insect-Sting Treatment Kits with the lot numbers, 0397, 0497, 0597, 8141, 8139, 11464, 13239, should be returned to the hospital, clinic or pharmacy where they were obtained. The numbers are found on the front label of the kit. The products were distributed between June 1997 and February 1999.
Ana-Kits with lot numers AK344 through AK363 and lot AK366, and Ana-Guard with lot numbers G00196 through G00220, and lots G00222 and G00223 should also be returned. Ana-Kit lot numbers are on the front label of the package, and Ana-Guard lot numbers are on the top panel of the box. They were distributed by Bayer between April 1997, and April 1998.
Only those specific lots of the product are affected by the recall, American Home said.