December 28, 1999Schering-Plough
HealthCare Recalls Tinactin Antifungal Powder
Memphis, TN (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Schering-Plough HealthCare is recalling Tinactin
Antifungal Powder, in 45, 90, and 108 gram shaker bottles, because the product was found
to be subpotent (stability).
This ongoing Class III recall was initiated
by the company by letter dated November 11, 1999. This is the first public notice
issued by the FDA.
428,000 bottles were sold nationwide
and bear the following lot numbers:
45 Gram: 8E15AAG,
8E16AG, 8E17AG, 8E18AG, 8H16AAG, 8H17AG, 8K24AAG, 8M03AG, 8N12AG
90 Gram: 8E10AG, 8E11AG, 8E13AG, 8E14AG, 8E15AG, 8E12AG 8E18AAG,
8G01AG, 8G01AAG, 8H13AG, 8H14AG, 8H15AG, 8H16AG
100 Gram: 9A06AG, 9A07AG, 9A08AG.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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