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FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.
December 1, 1999
We have just learned that some of the Vanceril 84 mcg Double Strength Convenience Pack inhalers may not contain drug substance and must be returned to the manufacturer. This situation should be considered serious and merits your immediate attention. It is important that you check your inhaler to see if it is from one of the batches listed above. If your Vanceril Double Strength Convenience Pack inhaler is from one of the recalled batches, please return it to your pharmacist.
You should not use inhalers from these batches. Using a canister without the drug ingredient would result in a lack of effectiveness, and you may experience increased asthma symptoms and need for additional asthma medications or medical treatment.
Please follow these steps right away.
We consider this matter to be serious and meriting serious attention. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
If have any questions, please contact the Recall Service Center (toll free) at (1-800-621-9760)
Thank you,
Adrienne Lee
Director/Respiratory Marketing
Key Pharmaceuticals
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