September 10, 2003
Recall Update: Breckenridge
Pharmaceutical Trionate Suspensio Recall is Complete
The Food and Drug Administration (FDA) released the following information.
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.
L021261, L021J011 and L02L111.
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.
Contamination; product complaints of black particulates and/or mold,
appearance changes and "off" taste.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Puerto Rico.