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

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