Recalls / Class II
Class IID-923-2013
Product
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.
- Brand name
- Lidocaine
- Generic name
- Lidocaine Hydrochloride And Epinephrine Bitartrate
- Active ingredients
- Epinephrine Bitartrate, Lidocaine Hydrochloride
- Route
- Submucosal
- NDC
- 66467-9730
- FDA application
- ANDA088390
- Affected lot / code info
- Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
Why it was recalled
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.
Recalling firm
- Firm
- Novocol Pharmaceutical of Canada
- Manufacturer
- Darby Dental Supply, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 25 Wolseley Court, Cambridge, N/A, Canada
Distribution
- Quantity
- 12,497 Boxes
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2013-08-14
- FDA classified
- 2013-08-26
- Posted by FDA
- 2013-09-04
- Terminated
- 2014-01-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-923-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.