• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.
Recall Number D-923-2013
Classification Class II
Code Info Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
Product Distributed Qty 12,497 Boxes
Reason For Recall Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.

Event Detail

Event Id 65979
Product Type Drugs
Status Ongoing
Recalling Firm Novocol Pharmaceutical of Canada
City Cambridge
State
Country CA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-14
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide and Canada
-
-