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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

Novocol Pharmaceutical Recalls Dental Anesthetics

PRODUCT
Rx dental anesthetics, in blister packed cartridges:
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-188/191-9.

CODE
(Product label is bold, Lot# and Date listed below)

Novocol Isocaine 3%
6291A July 1999
7041 October 1999
7158C January 2000
7411A August 2000
8014A September 2000
8028A September 2000
8152 January 2001 8213A February 2001
8274 May 2001
8332B July 2001
8358B July 2001
8359C July 2001

Henry Schein Private Label
6184 March 1999
6291B July 1999
7004A September 1999
7230 April 2000
7308 June 2000
7411B August 2000
7425B August 2000
8028B September 2000
8030A September 2000
8257B May 2001
8275B May 2001
8284B June 2001
8332A July 2001
8358A July 2001

Patterson Private Label
6340 August 1999
7004B September 1999
7156 January 2000
7377A July 2000
7377B July 2000
8014B September 2000
8024A September 2000
8024B September 2000
8276A May 2001
8331B July 2001

Carlisle Private Label
6342 August 1999
7158B January 2000
7231 April 2000
7231A April 2000
7407B August 2000
8214A February 2001
8257A May 2001
8359A July 2001

Meer Private Label
7066A November 1999
8284A June 2001

GENERIC NAME: Lidocaine Hydrochloride and Epinephrine Injection
USP TRADE NAME: Novocol Octocaine 50 and Novocol Octocaine 100

Novocol Octocaine (1:50,000)
7007 September 1998
8006C September 1999
8190C February 2000
8259C May 2000
8280 May 2000
8282B June 2000
8355C July 2000

Patterson Private Label (1:50,000)
7392A July 1999
8086B January 1999
8282A June 2000

Henry Schein Private Label (1:50,000)
7410B August 1999
7410C August 1999
8006B September 1999
8190B February 2000
8259B May 2000
8282C June 2000
8357B July 2000

Carlisle Private Label (1:50,000)
7426B August 1999
8259A May 2000
8355B July 2000
8357A July 2000

Novocol Octocaine (1:100,000)
7175 February 1999
7176 February 1999
7249 April 1999
7259 April 1999
7271 May 1999
7278 May 1999
7285 May 1999
7310 June 1999
7313 June 1999
7314 June 1999
7349 July 1999
7351 July 1999
7358B August 1999
7363 July 1999
7395 July 1999
7399 July 1999
7400 July 1999
7401 July 1999
7413B August 1999
7417 August 1999
8003 September 1999
8004 September 1999
8005 September 1999
8010 September 1999
8011 September 1999
8049 October 1999
8089A November 1999
8099 November 1999
8102 November 1999
8103B November 1999
8115 December 1999
8165A January 2000
8165B January 2000
8233 April 2000
8242 April 2000
8243 April 2000
8244 April 2000
8245 April 2000
8252B May 2000
8267 May 2000
8269B May 2000
8272 May 2000
8288 June 2000
8289 June 2000
8290 June 2000
8291 June 2000
8291A June 2000
8310 June 2000
8311 June 2000
8313 June 2000
8336 July 2000
8337 July 2000
8347 July 2000
8348 July 2000
8349 July 2000
8353 July 2000
8364 August 2000
8365 August 2000

Patterson Private Label (1:100,000)
7170 February 1999
7197 February 1999
7204 March 1999
7225 March 1999
7228B April 1999
7229B April 1999
7325 June 1999
7326 June 1999
7355 July 1999
7357 July 1999
7371 July 1999
7402 August 1999
7403 August 1999
8021 September 1999
8107 November 1999
8166 January 2000
8168 January 2000
8169 January 2000
8171 January 2000
8171A January 2000
8172 January 2000
8184 February 2000
8295 June 2000
8297 June 2000
8339 July 2000
8340 July 2000
8341 July 2000
8342 July 2000

Henry Schein Private Label (1:100,000)
7172 February 1999
7181 February 1999
7183 February 1999
7184 February 1999
7189B February 1999
7214 March 1999
7215 March 1999
7226 March 1999
7283 May 1999
7397 July 1999
7398 July 1999
7416 August 1999
7418 August 1999
7420 August 1999
7421 August 1999
7423B August 1999
8056 October 1999
8128 December 1999
8135 December 1999
8140 December 1999
8176 January 2000
8193 February 2000
8194 February 2000
8195 February 2000
8231 April 2000
8232 April 2000
8237 April 2000
8238 April 2000
8239 April 2000
8240 April 2000
8246 May 2000
8247 May 2000
8248 May 2000
8253 May 2000
8254 May 2000
8255 May 2000
8256 May 2000
8265 May 2000
8266 May 2000
8268 May 2000
8270 May 2000
8271 May 2000
8273 May 2000
8286 June 2000
8287 June 2000
8318 June 2000
8318A June 2000
8326 July 2000
8334 July 2000
8343 July 2000
8344 July 2000
8345 July 2000
8346 July 2000
8350 July 2000
8351 July 2000
8352 July 2000
8361 August 2000
8362 August 2000

Meer Private Label (1:100,000)
7209 March 1999
7419 August 1999
8031 September 1999
8216 February 2000
8241 April 2000

Carlisle Private Label (1:100,000)
7219 March 1999
7224 March 1999
7370 July 1999
7370A July 1999
8023 September 1999
8042B October 1999
8074 January 1999
8080 January 1999
8082 January 1999
8090 January 1999
8180 January 2000
8206 February 2000
8208 February 2000
8294 June 2000
8363 August 2000

GENERIC NAME: Mepivacaine Hydrochloride and Levonordefrin Injection USP
TRADE NAME: Novocol Isocaine 2%

Novocol Isocaine 2%
7168 February 1999
7301 June 1999
8043B October 1999
8235 April 2000
8236C April 2000
8279C May 2000
8333B July 2000
8360C August 2000

Henry Schein Private Label
7232 April 1999
7408C August 1999
8043C October 1999
8222A February 2000
8277B May 2000
8279B May 2000
8333A July 2000
8360A August 2000

Patterson Private Label
7233B April 1999
8116A December 1999
8116B December 1999
8279A May 2000
8333C July 2000

Carlisle Private Label
7408B August 1999
8222C February 2000
8236B April 2000
8360B August 2000

Meer Private Label
8222B February 2000.

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

RECALLED BY
Novocol Pharmaceutical of Canada, Inc., New Castle, Delaware, by telephone the first week in February 1999, and mailed letters on February 9, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Undetermined.

REASON
Lack of assurance of sterility.

 

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.