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

SafetyAlerts
December 14, 1999

Novocol Pharmaceutical Recalls Lidocaine  and Mepivacaine

Cambridge, Ontario (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Novocol Pharmaceutical is recalling Lidocaine and Epinephrine Injection, USP (Lidocaine HCl 2% and Epinephrine 1:100,000 and 1:50,000) and Mepivacaine Hydrochloride and Levonordefrin Injection, USP (Mepivacaine HCl 2% and Levonordefrin 1:20,000),  because the product is subpotent (Ephinehrine/Levonordefrin).

This ongoing Class III recall was initiated by the company, by telephone on September 27, 1999, and by letter on October 1, 1999. This is the first notice the FDA has issued to the general public of the recall.

The recalled product was products are shipped in 1.8 ml cartridges with 50 cartridges per box.

Over 52 boxes were distributed nationwide and bear the lot numbers and expiration dates of:

Lidocaine 100:
Lot # 8050 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8051 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8055* EXP 10/99 under Henry Schein label
Lot # 8056* EXP 10/99 under Henry Schein label
Lot # 8057 EXP 10/99 under Henry Schein label
Lot # 8064 EXP 10/99 under Henry Schein label
Lot # 8065 EXP 10/99 under Henry Schein label
Lot # 8066 EXP 10/99 under Meer Dental label
Lot # 8067 EXP 10/99 under Carlisle Laboratories label
Lot # 8068 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8069 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8071 EXP 10/99 under Meer Dental label
Lot # 8072 EXP 11/99 under Meer Dental label
Lot # 8073 EXP 11/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8074* EXP 11/99 under Carlisle Laboratories label
Lot # 8075 EXP 11/99 under Carlisle Laboratories label
Lot # 8076 EXP 11/99 under Carlisle Laboratories label
Lot # 8077 EXP 11/99 under Carlisle Laboratories label
Lot # 8078 EXP 11/99 under Carlisle Laboratories label
Lot # 8079 EXP 11/99 under Carlisle Laboratories label
Lot # 8080* EXP 11/99 under Carlisle Laboratories label
Lot # 8081* EXP 11/99 under Carlisle Laboratories label
Lot # 8082* EXP 11/99 under Carlisle Laboratories label

Lidocaine 50:
Lot # 8058 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8059C EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8060 EXP 10/99 under Henry Schein label
Lot # 8083 EXP 11/99 under Carlisle Laboratories label
Lot # 8086B* EXP 11/99 under Patterson Dental label

Mepivacaine 2%:
Lot # 8063B EXP 10/99 under Meer Dental label (Henry Schein now owns)
Lot # 8063C EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8063D EXP 10/99 under Carlisle Laboratories label

* Indicates that the lot was involved in a previous recall.  Click here to view.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
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: www.safetyalerts.com.

###

 

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.