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Contact: William O'Donnell
(973) 822-7476

WARRICK PHARMACEUTICALS ISSUES NATIONWIDE RECALL ON ONE LOT OF ALBUTEROL INHALER AEROSOL

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 package and on the canister 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 stores. Warrick is advising that the matter should be considered serious and one that merits immediate attention. The use of an affected canister by an asthma patient may cause adverse health consequences requiring medical treatment. 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 brief period during filling of the subject lot. Although the mechanical failure was detected and controls were in place to prevent any affected canisters from being distributed, it has been determined that at least one such unit was released. The company estimates that the maximum 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 prevent a recurrence.

Customers who have had prescriptions for Warrick albuterol inhaler filled since April 27, 1999, are advised to check the lot number and return 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.

Consumers with questions regarding the recall should consult their pharmacist or physician, 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 company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

September 9, 1999

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