December 8, 1999

Dear Pharmacist:

This letter is to inform you of an urgent drug product recall. Schering/Key is recalling the following batches of its VANCERIL 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol Convenience Pack, Batch Nos. 9-DMT-157, 9-DMT-158, 9-DMT-160, 9-DMT-161, and 9-DMT-163, expiration date of July 2000. Please note that no other batches of VANCERIL 84 mcg DOUBLE STRENGTH Convenience Pack is included in this recall. Schering/Key began distribution of these batches in November 1999.

We are conducting this recall to the user/patient level. The reason for our action is that there may be a small number of canisters that may not contain drug substance. It is important for patients to check with you to see if their Vanceril Double Strength Convenience Pack Inhaler needs to be returned. Patients using an affected canister without 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.

We are providing you with an information letter for patients whose prescriptions may have been filled using product from one of the recalled batches. Please call or mail this letter to patients who may have received an inhaler from one of the five batches noted above. Patients should be directed to return their inhaler to their pharmacist for a replacement Vanceril inhaler. If one is not available, please contact the patient's physician.

You will need to do the following:

1. For any inhalers brought back to you by patients, please check the batch number. If it is from one of the 5 recalled batches, replace the inhaler and return the affected inhaler as instructed below. If it from another batch not included in the recall, the inhaler can be used as dispensed.

2. Check your inventory to determine if you have any product on hand from the 5 affected batches.

3. Return any inhalers from the 5 affected batches to either your wholesaler or distributor, as appropriate. Credit will be issued on all returned quantities and reimbursement for your efforts will be in concert with the "NWDA Suggested Allowance Formula for Product Recalls".

If you should become aware of any adverse events, please contact Schering through the below referenced Recall Service Center or the FDA MEDWATCH program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail to MEDWATCH, HF-2, 5600 Fishers Lane, Rockville, MD 20857. [Report by Internet at: www.fda.gov/medwatch]

We consider this matter to be serious and meriting immediate attention. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

If you have any questions, please contact the Recall Service Center (toll free) at 1-800-621-9760.

We apologize for any inconvenience this recall might cause and we thank you for your cooperation.

Sincerely,

Adrienne Lee
Director/Respiratory Marketing
Key Pharmaceuticals