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EMERGENCY TREATMENT KITS RECALLED

 EMERGENCY TREATMENT KITS RECALLED
 WEST HAVEN, Conn., Dec. 23 /PRNewswire/ -- Miles Inc. said today


that as a result of a recall announced last week by a supplier, Wyeth- Ayerst Laboratories, Miles' Pharmaceutical Division had sent letters to more than 2,000 drug wholesalers, physicians and pharmacists notifying them that epinephrine injection units they received for use by patients in medical emergencies have been found to be below the potency level stated on the package.
 Customers were requested to return the units for a full refund.
 The recall, which was first announced by Wyeth-Ayerst on Dec. 13, involves 2,000,000 epinephrine injection units. These include 350,000 units utilized in the ANA-KIT(R) Anaphylaxis Emergency Treatment Kit and certain other products distributed by the Miles' allergy products business group, Hollister-Stier.
 Epinephrine is frequently used to treat cardiac seizure cases and anaphylactic shock patients and is commonly used in hospital emergency rooms.
 Wyeth-Ayerst, which has notified FDA of the recall, said the epinephrine injection units were made between August 1989 and July 1990 and were packaged in 1 ml Tubex(R) sterile cartridge units and have been distributed worldwide.
 In addition to its other uses, epinephrine is packaged in ANA-KIT products to treat severe allergic reactions to such things as bee stings or to treat severe asthmatic attacks.
 Wyeth-Ayerst is investigating why the epinephrine in the rubber- stopper sealed sterile glass vials lost its potency.
 According to Hollister-Stier, because of the emergency-use nature of the product, patients with allergy problems are usually aware of expiration dates on the injection kits. Normally over the course of a year an estimated 2 percent to 5 percent of the epinephrine injection kits are actually used by allergy patients. The dosage in the kits is believed to be larger than most people would require and the efficacy implications for a sub-potent product are unclear, according to Hollister-Stier.
 Patients will recall-affected products should return them to where they were purchased and exchange them for new products.
 The Hollister-Stier lot numbers involved in this recall are:
 -- ANA-KIT(R) Anaphylaxis Emergency Treatment Kit AK272, AK273, AK274, AK275, AK276, AK277, AK278, AK279
 -- ANA-GUARD(TM) Epinephrine Injection, USP (1:1000) G00017 through G00073 (sequentially)
 -- Epinephrine Injection, USP (1:1000) Refill S218, S219, S220, S221, S222, S223
 Hollister-Stier said all the products originally left its facilities in Spokane, Wash., meeting all standards.
 -0- 12/23/91
 /CONTACT: Don Hyman of Miles, 203-498-6545, or home, 203-255-9093; Hollister-Stier Assistance, 800-225-6443; or Brad Stone of the FDA, 301-443-3285/ CO: Miles Inc. ST: Connecticut IN: MTC SU:


JT-KD -- NY044 -- 4850 12/23/91 12:56 EST
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Publication:PR Newswire
Date:Dec 23, 1991
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