Vanceril (beclomethasone dipropionate) Dear Healthcare Professional Letter Mar 2000
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.
This is the retyped text of a letter from Schering Laboratories. Contact the company for a copy of any referenced enclosures.
March 29, 2000
URGENT—DRUG PRODUCT RECALL
VANCERIL® 42 mcg Inhalation Aerosol (16.8g/200inhalations),
VANCERIL® 42 mcg Inhalation Aerosol Institutional Pack (6.7g/80inhalations),
VANCERIL® 84 mcg DOUBLE STRENGTH Inhalation Aerosol (12.2g/120 inhalations),
VANCERIL® 84 mcg DOUBLE STRENGTH Inhalation Aerosol (5.4g/40 inhalations),
VANCERIL® 42 mcg (beclomethasone dipropionate, 42 mcg) Inhalation Aerosol
Batch numbers 8-AMA-208 thru 8-AMA-703 and batch numbers 9-AMA-200 thru 9-AMA-404.
VANCERIL® 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol
Batch numbers 8-DMT-644 thru 8-DMT-646 and batch numbers 9-DMT-133 thru 9-DMT-621.
This letter is to inform you of a drug product recall. Schering/Key is voluntarily recalling the following batches of VANCERIL® 42 mcg Inhalation Aerosol: batch numbers 8-AMA-208 thru 8-AMA-703 and batch numbers 9-AMA-200 thru 9-AMA-404. VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol: batch numbers 8-DMT-644 thru 8-DMT-646 and batch numbers 9-DMT-133 thru 9-DMT-621.
Please note that no other batches of VANCERIL 42 mcg and VANCERILÒ 84 mcg DOUBLE STRENGTH Inhalation Aerosol products are included in this recall. Also, any product with an expiration date of October 2001 or later (product manufactured after September 30, 1999) is not included in this recall.
Schering is issuing this recall as a precaution to address the remote possibility that an aerosol inhaler may not contain active drug, although the company believes that all of its aerosol products currently in the marketplace are safe and effective. This recall relates to an aerosol manufacturing problem that had been previously identified in October 1999 and information regarding correction of this problem was provided to FDA
We are conducting this recall at the patient, wholesale and retail level. Patients will be alerted to this recall through a press release (copy enclosed) and a placard displayed in the pharmacy. Patients are being instructed to return inhalers from these batches to their pharmacy. If no replacement VANCERIL® Inhaler is available, the pharmacist may contact you to discuss alternatives. If they have any questions, they are instructed to call the Recall Services Center at 1-800-621-9760 or visit the recall web site at www.rxrecall.net.
If you should become aware of any adverse events associated with these batches, 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.
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.
Melvyn Bloom, M.D.