Warrick Albuterol

Warrick Pharmaceuticals is voluntarily recalling a specific lot of albuterol metered-dose inhaler aerosol 17 g, a prescription medication for the treatment of asthma. The company is taking this action after one patient returned an inhaler that did not have drug substance.

The recall affects lot No. 9-BBS-525, which was distributed by Warrick between late April and early May 1999. The inhalers have an expiration date of August 2001. The lot number and expiration date appear on either the top or bottom flaps of the packet and on the container label. No other lots of Warrick albuterol inhalers are involved.

The recall is being extended to individual patients, pharmacies and direct accounts such as wholesalers and chain drug supplies. Warrick is advising that the matter should be considered critical and one that merits urgent attention. The use of an affected container by an asthma patient may initiate adverse health consequences requiring medical care. The recall is being conducted in cooperation with the U.S. Food and Drug Administration.

To date, there have been no reported medical adverse events related to the recalled lot. The cause of the problem has been identified as an isolated mechanical failure that occurred for a short period during filling of the subject lot. Although the mechanical breakdown was detected and controls were in place to avoid any affected canisters from being distributed, it has been determined that at least one such piece was released. The company estimates that the greatest number of affected units that might have been produced was fewer than 150 canisters out of the total production run of 190,000 units. The company has taken corrective actions to avoid a recurrence.

Customers who have had prescriptions for Warrick albuterol inhaler filled since April 27, 1999, are advised to confirm the lot number and send any inhalers from the subject lot to the pharmacy for replacement. Pharmacists have been notified. Direct-account customers have been asked to return any units from the subject lot on hand and to request that their customers return any units from the subject lot to them.

Patrons with questions about the recall should consult their pharmacist or doctor, or call Warrick Pharmaceuticals at (toll free) 1-877-278-3045.

Warrick Pharmaceuticals is the generic pharmaceutical marketing subsidiary of Schering-Plough Corporation, a research-based business engaged in the discovery, development, manufacturing and marketing of pharmaceutical goods worldwide.

September 9, 1999, albuterol recall, albuterol shortage