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DRUG RECALL BY PHARMACEUTICAL BASICS

DRUG RECALL BY PHARMACEUTICAL BASICS
    MORTON GROVE, Ill., June 15 /PRNewswire/ -- Pharmaceutical Basics, Inc. (PBI) of Morton Grove, Ill., in cooperation with the Food and Drug Administration, is voluntarily recalling all lots of Metaproterenol Sulfate Inhalation Solution, USP five percent having an expiration date later than May 1, 1992.  Metaproterenol Sulfate Inhalation Solution, USP five percent is a prescription drug dispensed to patients with bronchial asthma or experiencing reversible bronchospasm associated with bronchitis or emphysema.  The recall is being conducted as a result of routine testing by PBI, which disclosed the presence of microbial growth exceeding specified limits in certain lots, e.g., Pseudomonas gladioli/cepacia.  The recall applies to all unexpired lots even though excessive microbial growth has been confirmed only in limited lots.  The recalled PBI lots were marketed under the labels of the following companies:  Dey Laboratories, Inc.; Goldline Laboratories; H.L. Moore; Qualitest Products, Inc.; Pharmaceutical Basics, Inc.; and Rugby Laboratories, Inc.
    The product was distributed nationwide and the estimated quantity remaining on the market is approximately 16,000 units.
    Metaproterenol Sulfate Inhalation Solution, USP five percent, is clear to pale yellow in color, and the dropper is graduated showing 0.2 and 0.3 ml black lines.
    The presence of excessive microbial growth in Metaproterenol Sulfate Inhalation Solution, USP five percent poses a risk of potential serious pulmonary infections to all patients for whom the drug would be prescribed.  The FDA has determined that this situation represents a particularly serious heath hazard, which may be life-threatening, to patients with chronic obstructive airway disease, with cystic fibrosis (CF), or with compromised immune systems.
    PBI is requesting all pharmacists to review their dispensing records for the period April 1, 1992 to the present and to notify any patient dispensed any of the recalled lots to immediately contact their physician regarding a replacement medication.
    PBI requests all patients who have any of this product from a lot having an expiration date later than May 1, 1992, 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 Metaproterenol Sulfate Inhalation Solution, USP five percent to their pharmacist.
    -0-             06/15/92
    CONTACT:  Pharmaceutical Basics, Inc., 1-800-445-8091, or 312-380-0080 CO:  PHARMACEUTICAL BASICS, INC. IN:  MTC ST:  IL -- NY045 -- X548  06/15/92
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Publication:PR Newswire
Date:Jun 15, 1992
Words:387
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