Lidocaine Injection, Solution
FDA Recall NDC 66467-9730
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lidocaine (NDC 66467-9730). A significant event, classified as Class II, was initiated on Aug 14, 2013 by Darby Dental Supply, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2013 Class II Recall: Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1
Recall Number
Class II Terminated
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.
Aug 14, 2013
Sep 04, 2013
12,497 Boxes
Recall Profile & Regulatory Data
Event ID
65979
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Novocol Pharmaceutical of Canada
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Canada
Termination Date
Jan 07, 2014
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.
Batch or Lot Expiration Information
Lot# s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
Affected Packages Involved in this Recall
66467-9730-5Product
0362-9023-05Product
42756-1030-5Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
