[MOL] Recall: Anyone going to the dentist? [03373] Medicine On Line


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[MOL] Recall: Anyone going to the dentist?



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,

Lidocaine Hydrochloride 3% and Epinephrine Injection, USP 1:100,000
LOT NOS. 7102, 7182, 7284, 7270A, 7309, 8157, 8162A, 8162, 8163, 8164, 8249,

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.