D-923-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2013
- Initiation Date
- August 14, 2013
- Termination Date
- January 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,497 Boxes
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.
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.
Distribution Pattern
Nationwide and Canada
Code Information
Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013