CLASS I RECALL - NOVOCOL PHARMACEUTICAL OF CANADA, INC.
During a
recent FDA inspection of Novocol Pharmaceutical of Canada in Ontario, Canada,
the firm was found to be non-compliant with Current Good Manufacturing
Practices (CGMP's) regarding sterile drug production of some of its
dental anesthetic injectable cartridge products. Organisms found by the firm
during its own USP Sterility Testing of final product included
Staphyloccous auricularis, Staphyloccous epidermis, and Enterococcus
faecalis. There was insufficient information to rule out these organisms
as being from the test environment rather than the products
themselves.
On January 14, 1999, the firm voluntarily recalled several
injectable dental cartridges from the market based on questions raised
regarding the sterility of certain lot numbers and the company's current good
manufacturing practices.
The products and lot numbers are as
follows:
Lidocaine Hydrochloride 2% and Epinephrine Injection, USP
1:50,000 LOT NOS. 7412B, 7412C, 8081, 8207, 8159, 8161B,
Mepivacaine
Hydrochloride Injection, USP 3% LOT NOS. 7157
Mepivacaine
Hydrochloride 2% and Levonordefrin Injection, USP. 1:20,000 LOT NOS. 7412A,
8160
These products are sold in 20 packages of 50 cartridges containing
1.8 ml of product per cartidge under the Henry Schein Inc., Melville, NY,
Carlisle Laboratories, Inc., Rockville Center, NY. and Novocol brand
names.
The recall is being conducted by the firm's U.S. location in New
Castle, Delaware and questions regarding this recall should be directed to
this firm at 1-800-872-8305. Additional lots of these product will also be
voluntarily recalled by the firm due to lack of assurance of sterility a
Class II recall as assigned by the agency. Consignees of all products under
recall are being notified by Novocol via letter with return
instructions.
