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SafetyAlerts
February 22, 2001

Levsinex Recalled for Mislabeling

Madison, WI (SafetyAlerts) - The Food and Drug Administration (FDA) said today that RightPak, Inc. is  recalling certain lots of Levsinex because the product was packaged with incorrect insert, providing incorrect description of capsules (mislabeling).

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Levsinex 0.375 mg (Hyoscyamine Sulfate USP 0.375 mg), 100 (extended release)Timecaps Capsules per bottle.

Recall #D-091-1.

CODES:
OEO2119 (expiration date 1-02)
OHO3126 (expiration date 4-02)
OHO3170 (expiration date 5-02)

MANUFACTURER:
Schwarz Pharma, Inc., Seymour, IN .

RECALLED BY:
RightPak, Inc., Madison, WI, by e-mail on 1/11/01. Firm-
initiated recall ongoing.

DISTRIBUTION:
Nationwide and Puerto Rico.

QUANTITY:
1,409 bottles.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers February 22, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.