December 2, 1999Schering/Key
Pharmaceuticals Vanceril 84 mcg Double Stength Recalled
Kenilworth, NJ (SafetyAlerts) - Schering/Key
Pharmaceuticals today announced a voluntary recall of five lots of Vanceril 84 mcg Double
Stength (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol Convenience Pack, a
prescription medication for the maintenance treatment of asthma. The company is taking
this action because it has determined that a number of canisters in the five lots listed
below may not contain the active drug.
Schering/Key is advising that the
matter should be considered very serious and one that merits immediate attention. Patients
using an affected canister without the active drug would be expected to experience a lack
of effectiveness which may result in increased asthma symptoms, need for other asthma
medications, emergency room visits or hospitalization.
Because of the nature of the problem,
a patient cannot determine whether they have an affected metered dose inhaler (MDI) just
by actuating their MDI. An affected MDI may appear to emit an aerosol even if it does not
contain active drug.
The recalled lots were distributed nationwide in
November and have the numbers 9-DMT-157, 9-DMT-158, 9-DMT-160, 9-DMT-161 and 9-DMT-163.
The inhalers have an expiration date of July 2000. The lot number and expiration
date appear on either the top or bottom flaps of the package and on the canister label. No
other lots of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol Convenience Pack are
The recall is being conducted with the knowledge
of the U.S. Food and Drug Administration. There have been no reported medical adverse
events related to the recalled lots.
The cause of the problem has been identified as
inadequate batch start-up practices that occurred for a short period during filling of the
subject lots. The company has taken corrective actions to prevent a recurrence.
The recall is being extended to individual
patients, pharmacies and direct-account customers such as wholesalers and chain drug
stores. Direct-account customers have been asked to return any units from the subject lots
on hand and to request that their customers return any units from the subject lots to
Patients who have had prescriptions for VANCERIL
84 mcg DOUBLE STRENGTH Inhalation Aerosol Convenience Pack filled since November 1999 are
advised to check the lot numbers and return any inhalers from the subject lots to the
pharmacy for free replacement.
Any questions regarding the recall should be
directed to the Recall Services Center (toll free) at 1-800-621-9760.
Schering/Key Pharmaceuticals is a business unit of
Schering Laboratories, the U.S. pharmaceutical marketing arm of Schering-Plough
Corporation (NYSE: SGP) of Madison, N.J., a research-based company engaged in the
discovery, development, manufacturing and marketing of pharmaceutical products worldwide.
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