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Safety Alerts
August 25, 1999

Hoechst Marion Roussel, Inc. Recalls Allegra-DÆ Extended Release Tablets

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.

PRODUCT
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

CODE
Lot #98069654, EXP 7/99 - 100-tablet blister strip boxes (10/10-tablet strips), NDC #0088-1090-49
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.

MANUFACTURER
Hoechst Marion Roussel, Inc., Kansas City, Missouri.

RECALLED BY
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 ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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 4/3/98-5/27/98
100-tablet bottles - 90,676 bottles between 4/27/98-6/22/98.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

 

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.