June 21, 2001Z-52 Nighttime Sleep Aids
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.
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.
Lot 6072 exp.JAN 02.
Nittany Pharmaceuticals, Inc., Milroy PA.
Manufacturer, by telephone and by letter on 5/18/01. Firm initiated recall is ongoing.
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.