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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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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