April 12, 2001True Care Decongestant Nasal
Burnsville, MN (SafetyAlerts) - The
Food and Drug Administration (FDA) said today that Apothecary Products, Inc. has recalled
certain True Care Decongestant Nasal Spray because of mislabeling; Failure to declare
warning against use if heart disease exists.
This is the first public notice of
this Class III
recall issued by FDA.
True Care Decongestant Nasal Spray, 1/2 fl. oz., Ozymetazoline Hydrochoride
0.05%, NDC 57394-608-06.
Thames Pharmaceutical Co. inc., Ronkonkoma, NY.
Apothecary Products, INC., South Burnsville, MN.
Kansas City, MO.
About 920 mislabeled 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 April
12, 2001. For more information regarding the SafetyAlerts free email alert service
please click here.