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SafetyAlerts
September 20, 2000

Levsinex(tm) Capsules Recalled for Mislabeling

Lexington, NE (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Med-Pro, Inc.  is recalling its Levsinex(tm) Capsules a Rx for use as adjunctive therapy in the treatment of peptic ulcer because Insert incorrectly states product has a clear capsule body and contains beadlets, product actually has a white capsule body and contains a tablet.

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

PRODUCT
Levsinex(tm) Capsules (Hyoscyamine Sulfate, USP), 0/375 mg, Timecap Extended Release, Rx for use as adjunctive therapy in the treatment of peptic ulcer. NDC #0091-3537-01.

Recall #D-464-0.

CODE
Lot #02580K EXP 2002.

MANUFACTURER
Schwarz Pharma, Seymour, Indiana.

RECALLED BY
Med-Pro, Inc., Lexington, Nebraska, by telephone on August 11, 2000, and by letter dated August 15, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
New York.

QUANTITY
299 bottles were distributed.

 
Selected Recent Recalls


Health Professional:

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

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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.