Safety Alerts Saves Lives
Safety Alerts  
Home Privacy About Us Contact Us Change Preferences

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.

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.

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.

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?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit:



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.