September 20, 2000Knoll Pharmaceutical Company
Recalls Certain Lots of Vicodin(r) Tablets
Olive, NJ (SafetyAlerts) - The Food
and Drug Administration (FDA) has announced that Knoll Pharmaceutical Company is recalling
its Vicodin(r) Tablets (Hydrocodone bitartrate 5 mg and Acetaminophen 500 mg), in 500
count bottles because of dissolution failure.
This is the first public notice of
this Class III
recall issued by FDA.
Vicodin(r) Tablets (Hydrocodone bitartrate 5 mg and Acetaminophen 500 mg), in 500
count bottles, Rx indicated for the relief of moderate to moderately severe pain.
NDC Number Lot Number EXP Date Bottle Size
0044-0727-03 1076-0418 09/2002 500 count
0044-0727-03 1076-0428 09/2002 500 count
0044-0727-03 1076-0438 09/2002 500 count.
Knoll Pharmaceutical Company, Whippany, New Jersey.
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by letter on August 11, 2000.
Firm-initiated recall ongoing.
8,222 bottles were distributed; firm estimates none remains on the market.
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