
SafetyAlerts
September 20, 2000Nitroglycerin Sublingual
Tablets Recalled for Contamination
Tucson,
AZ (SafetyAlerts) - The Food and
Drug Administration (FDA) has announced that Konec Limited Liability Company is recalling
its Nitroglycerin Sublingual Tablets because metal particle contamination.
This is the first public notice of
this Class II
recall issued by FDA.
PRODUCT
Nitroglycerin Sublingual Tablets, 0.4 mg, in 25 and 100-count amber glass
bottles.
Recall #D-461-0.
CODE
N419R1 (25 tablets each) NDC 60951-718-25
N419W1 (25 tablets each) NDC 60951-718-25
N459W1 (100 tablets each) NDC 60951-718-70.
MANUFACTURER
Konec Limited Liability Company, Tucson, Arizona.
RECALLED BY
Manufacturer, by telephone on or about February 13, 2000. Firm-initiated recall
**complete.
**Completed recall: While the FDA has completed
processing of this particular recall, it does not mean this particular product has been
fully accounted for.
DISTRIBUTION
Pennsylvania.
QUANTITY
N419R1: 8,891 bottles of 25 tablets each
N419W1: 16,726 bottles of 25 tablets each
N459W1: 4,719 bottles of 100 tablets each.
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