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Safety Alerts
September 14, 1999

Tenormin IV Recalled by AstraZenec

Cherry Hill, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that AstraZeneca, A Business Unit of Zeneca, Inc. is recalling Tenormin IV because of current good manufacturing practice deviations (at contract manufacturer).

PRODUCT
Tenormin IV (Atenolol) 5mg/10ml ampules, Rx used for acute myocardial infarction. The product is shipped in cases of 60 ampules under the Zeneca Pharmaceuticals label.NDC 0310-0108-10.

Recall #D-409-9.  Class II

CODE
Lot Numbers: 3263B EXP 2/1/02, 3237B EXP 3/1/02, 3238B EXP 3/1/02, 3825A EXP 6/1/01, 3826A EXP 6/1/01, 3827A EXP 6/1/01, 3828A EXP 6/1/01, 3829A EXP 7/1/01, 4190A EXP 9/1/01, 4191A EXP 9/1/01, 4192A EXP 9/1/01, 8005A EXP 2/1/01, 8006A EXP 2/1/01, and 8014A EXP 3/1/01.

MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.

RECALLED BY
AstraZeneca, A Business Unit of Zeneca, Inc., Wilmington, Delaware, by letter on August 13, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Firm estimated that little product remained on market at time of recall initiation.

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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.