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December 26, 2000

Phenazopyridine Hydrochloride Tablets Recalled

Charlotte, NC (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Vintage Pharmaceuticals, Inc. is recalling Phenazopyridine Hydrochloride Tablets, USP, 100 mg, in 100-count bottles because of dissolution failure.

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

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, in 100-count bottles, Rx for the symptomatic relief of pain burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa.

Recall #D-062-1.

Lot #046060.

Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

Manufacturer, by letter dated July 24, 2000. Firm-initiated recall ongoing.


16,987 units were distributed.

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 December 26, 2000.  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.