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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 3, 1999

PRODUCT
Rx Dental anesthetics in blister packed cartridges, under the
following labels:  Novocol, Henry Schein, or Carlisle:
a) Lidocaine Hydrochloride 2% and Epinephrine Injection, USP
1:50,000;
b) Lidocaine Hydrochloride 3% and Epinephrine Injection, USP
1:100,000;
c) Mepivacaine Hydrochloride Injection, USP 3%;
d) Mepivacaine Hydrochloride 2% and Levonordefrin Injection, USP.
1:20,000.  Recall #D-119/122-9.

CODE
Lot numbers: a) 7412B, 7412C, 8081, 8207, 8159, 8161B; b) 7102, 7182, 7284, 7270A, 7309, 8157, 8162A, 8162, 8163, 8164, 8249; c) 7157; d) 7412A, 8160.

MANUFACTURER
Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada.

RECALLED BY
Novocol Pharmaceutical of Canada, Inc., New castle, Delaware, by letter on January 14-15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Undetermined.

REASON
Microbial contamination.

 

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.