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September 10, 2003

Recall Update: Breckenridge Pharmaceutical Trionate Suspensio Recall is Complete

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Trionate Suspension (Each 5 mL (one teaspoon full) contains: Carbetapentane Tannate, 30mg and Chlorphentramine Tannate, 4mg), RX only, Net Contents: 16 fl. oz. (one pint) 473 mL, NDC 51991-071-16. Recall # D-309-3.

CODE
L021261, L021J011 and L02L111.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Breckenridge Pharmaceutical Inc., Boca Raton, FL, by letters on March 18, 2003.
Manufacturing Firm: Unigen Pharmaceuticals, Inc. Westminster, MD. Firm initiated recall is complete.

REASON
Contamination; product complaints of black particulates and/or mold, appearance changes and "off" taste.

VOLUME OF PRODUCT IN COMMERCE
4,242 bottles.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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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.