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