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SafetyAlerts
June 21, 2001

Z-52 Nighttime Sleep Aids Recalled

Milroy, PA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Nittany Pharmaceuticals Inc. has recalled certain Z-52 Nighttime Sleep Aids because it is misbranded; product is labeled with an expiration date having no supporting stability data.

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

PRODUCT
Z-52 Nighttime Sleep Aid (Diphenhydramine HCI) 50 mg. Tablets. The product is sold in 50 count bottles; one case contained 144 bottles.

Recall # D-232-1.

CODES:
Lot 6072 exp.JAN 02.

MANUFACTURER:
Nittany Pharmaceuticals, Inc., Milroy PA.

RECALLED BY:
Manufacturer, by telephone and by letter on 5/18/01. Firm initiated recall is ongoing.

DISTRIBUTION:
IN.

QUANTITY:
144 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 June 21, 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!

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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.