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 CANTON, Mass., Jan. 5 /PRNewswire/ -- Copley Pharmaceutical, Inc. (NASDAQ-NMS: CPLY), today announced the voluntary recall of all lots of its 20 milliliter vials of Albuterol Sulfate Inhalation Solution, 0.5 percent, due to microbial contamination that has been found in certain manufacturing lots.
 Albuterol Sulfate Inhalation Solution is widely used by asthma patients and others with respiratory ailments as a bronchodilator to help them breathe easier.
 "Seriously ill persons such as those with a compromised immune system, including persons with AIDS and cancer patients who are undergoing chemotherapy or radiation treatment, persons with cystic fibrosis or chronic obstructive lung disease may be at special risk of potentially serious infections if using the recalled product. These patients are advised to consult their physician immediately," said Kenneth Zack, M.D., corporate medical director at Copley.
 "Asthma patients and other Albuterol patients who are otherwise healthy are at minimum risk from using this product," Zack stated.
 Consumers who are using Albuterol Sulfate Inhalation Solution 0.5 percent manufactured by Copley and distributed by Copley or by any of the following private labels should stop using the product at once and return any unused portions to their pharmacist. Other distributors of the product are Aligen, Astra, Geneva, Goldine, Harber, Major, Moore, H.L. Moore, Qualitest, Rugby and Schein. This recall does not affect the Albuterol Sulfate Inhalation Solution 0.083 percent product manufactured by Copley.
 Copley's routine quality assurance procedures discovered the presence of microbial organisms, such as Pseudomonas fluorescens, in some packages of the Albuterol product. The company is issuing this nationwide voluntary recall in cooperation with the Food and Drug Administration.
 Copley is requesting all pharmacists to review their dispensing records for the period Dec. 1, 1991, to the present and to notify any patient dispensed any lot of Albuterol Inhalation Solution 0.5 percent to immediately contact their physician regarding replacement medication.
 Copley requests all patients who have any of the recalled product with an expiration of or before December 1995, whether or not they have been contacted by a pharmacist, to immediately consult their physician regarding a replacement medication. Patients should promptly return the recalled Albuterol Inhalation Solution 0.5 percent product to their pharmacist.
 Copley Pharmaceutical, Inc., is a leading manufacturer and marketer of a broad range of off-patent prescription and over-the-counter pharmaceuticals in a variety of dosages.
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 /CONTACT: Steven Tannenbaum of Copley Pharmaceutical, 800-325-6111/

CO: Copley Pharmaceutical, Inc. ST: Massachusetts IN: MTC SU:

DT-DC -- DC020 -- 9478 01/05/94 16:37 EST
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Publication:PR Newswire
Date:Jan 5, 1994

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