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SafetyAlerts
September 20, 2000

Knoll Pharmaceutical Company Recalls Certain Lots of Vicodin(r) Tablets

Mount 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.

PRODUCT
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.

Recall #D-456-0.

CODE
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.

MANUFACTURER
Knoll Pharmaceutical Company, Whippany, New Jersey.

RECALLED BY
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by letter on August 11, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
8,222 bottles were distributed; firm estimates none remains on the market.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.