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SafetyAlerts
May 2, 2002

Integrity Pharmaceutical Has Recalled Urimax tablets

Indianapolis, IN (SafetyAlerts) - The Food and Drug Administration (FDA) said that Integrity Pharmaceutical Corp has recalled Urimax tablets.

PRODUCT
Urimax tablets in 100 count bottles and 2 tablet patient sample package, Rx, NDC 64731-860-01. Recall # D-244-2.
Each tablet contains:
Methenamine 81.60 mg
Sodium Biphosphate 40.80 mg
Phenyl salicylate 36.20 mg
Methylene Blue 10.80 mg
Hyoscyamine Sulfate 0.12 mg

CODE
Lots 01101, 10202, 10309, 10406, 10502, 108012, 109001 and 110083.

RECALLING FIRM/MANUFACTURER
Integrity Pharmaceutical Corp., Indianapolis, IN, by letter
dated March 28, 2002. Firm initiated recall is ongoing.

REASON
Subpotent for one ingredient (hyoscyamine) at stabilty testing.

VOLUME OF PRODUCT IN COMMERCE
55,800 bottles.

DISTRIBUTION
Nationwide.

 
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During 2000 there were over
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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.