Marion Roussel, Inc. Recalls Allegra-DÆ Extended Release Tablets
August 25, 1999
Kansas City, MO (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Hoechst Marion Roussel, Inc. is recalling
Allegra-DÆ Extended Release Tablets because of dissolution rate failure.
Allegra-DÆ Extended Release Tablets
(Fexofenadine HCL 60 mg and Pseudoephedrine HCL 120 mg), in physician (6ís) samples, 30
and 100 tablet bottles/blister strips, Rx, for the relief of symptoms associated with
seasonal allergic rhinitis.
Recall #D-309-9. Class III
Lot #98069654, EXP 7/99 - 100-tablet blister strip boxes (10/10-tablet strips), NDC
Lot #98069082, EXP 7/99 - 30-tablet physician sample bottles, no NDC number
Lot #98071706, EXP 8/99 - 30-tablet physician sample bottles
Lot #98071693, EXP 8/99 - Physician blister samples, no NDCnumber
Lot #98071987, EXP 8/99 - Physician blister samples
Lot #98073257, EXP 9/99 - 100-tablet bottles, NDC #0088-1090-47
Lot #98073353, EXP 9/99 - 100-tablet bottles
Lot #98073354, EXP 9/99 - 100-tablet bottles
Lot #98072117, EXP 10/99 - Physician blister samples
Lot #98072972, EXP 10/99 - Physician blister samples
Lot #98073503, EXP 10/99 - Physician blister samples
Lot #98073641, EXP 10/99 - 100-tablet bottles
Lot #98073642, EXP 10/99 - 100-tablet bottles
Lot #98073920, EXP 10/99 - 100-tablet bottles
Lot #98074492, EXP 11/99 - 100-tablet bottles.
Hoechst Marion Roussel, Inc., Kansas City, Missouri.
Manufacturer, by voice mail, E-mail and letter faxed on May 17, 1999, and second
E-mail on May 20, 1999, followed by telephone on May 28, 1999. Firm-initiated recall
The firm has distributed the following amounts of product:
100-tablet blister strip boxes - 5,326 boxes between3/5/98-12/22/98
30-tablet bottles (physician samples) - 62,514 bottles between 2/13/98-11/3/98
Physician blister samples - 129,264 boxes containing 8/3-day starter boxes between
100-tablet bottles - 90,676 bottles between 4/27/98-6/22/98.
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