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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
September 30, 1998

PRODUCT
Pacerone Amiodarone HCl 200 mg Tablets, 60 Tablets per bottle, NDC number 0245-0147-60; and in unit dose packets, 100 unit dose packets per carton, NDC number 0245-0147-01. Recall #D-239-8.

CODE
S:Lots 17775 and 17776 of 60-tablet bottles; and lot 17790 of unit dose packets.

MANUFACTURER
Upsher-Smith Laboratories, Inc., Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone beginning on August 21, 1998, and by letter dated August 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
27,062 60-tablet bottles and 1,240 unit dose, 100-tablet cartons were distributed.

REASON
Superpotency.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.