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U.S. Department of Health and Human Services

Safety

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Proventil (albuterol) 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/Key. Contact the company for a copy of any referenced enclosures.

URGENT - DRUG PRODUCT RECALL
Schering/Key
PROVENTIL® brand of albuterol, USP Inhalation Aerosol (17g/200 inhalations).
PROVENTIL® brand of albuterol, USP Inhalation Aerosol Refill (17g/200 inhalations).
PROVENTIL® brand of albuterol, USP, Inhalation Aerosol Institutional Pack (6.8%g/80 inhalations).
Warrick brand of albuterol, USP inhalation Aerosol (17g/200 inhalations).
Warrick brand of albuterol, USP inhalation Aerosol Refill (17g/200 inhalations)

 

Batch Numbers:

PROVENTIL® brand of albuterol, USP Inhalation Aerosol, and Warrick brand of albuterol, USP Inhalation Aerosol:

Batch number 7-BBS-303 thru 7-BBS-642, batch numbers 8-BBS-500 thru 8-BBS-826 and batch numbers 9-BBS-500 thru 9-BBS-832, except for those already opened albuterol inhalers that patients are currently using with good results.

Dear Doctor:

This letter is to inform you of a drug product recall, Schering/Key is recalling the following batches of PROVENTIL#&174 brand of albuterol, USP Inhalation Aerosol, and Warrick brand of albuterol, USP Inhalation Aerosol: Batch numbers 7-BBS-303 thru 7-BBS-642, batch numbers 8-BBS-500 thru 8-BBS-826 and batch numbers 9-BBS-500 thru 9-BBS-832, except for those already opened albuterol inhalers that patients are currently using with good results. This recall also pertains to products labeled as Major Albuterol Inhalation Aerosol, Martec Albuterol Inhalatiion Aerosol, Novopharm Albuterol Inhalation Aerosol, Qualitest Albuterol Inhalation Aerosol, Schein Albuterol Inhalation Aerosol, and URL, Albuterol Inhalation Aerosol.

Please note that no other batches of PROVENTIL® brand of albuterol, USP Inhalation Aerosol, Warrick brand of albuterol, USP Inhalation Aerosol products are included in this recall. Also, this recall does not affect PROVENTIL HFA (albuterol sulfate, USP) Inhalation Aerosol, or any product with an expiration date of October 2001 or later (product manufactured after September 30, 1999.)

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 market place 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 placed displayed in the pharmacy. Patients are being advised that if they are using their already opened PROVENTIL, or Warrick brand of albuterol inhaler with good results, they do not need to replace their inhaler. Additionally, if patients have any PROVENTIL, or Warrick brand of albuterol inhalers from these lots which were never used, they are being instructed to return them to their pharmacy. If they have any questions, they are instructed to call the Recall Services Center 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.

Sincerely,

Melvyn Bloom, M.D.
Director Allergy
Clinical Research/CNS