September 20, 2000Levsinex(tm) Capsules Recalled
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.
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
Lot #02580K EXP 2002.
Schwarz Pharma, Seymour, Indiana.
Med-Pro, Inc., Lexington, Nebraska, by telephone on August 11, 2000, and by letter dated
August 15, 2000. Firm-initiated recall ongoing.
299 bottles were distributed.
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