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.
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.
Lot numbers, UPCs & expiration codes
Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
Where it was sold
Nationwide and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-923-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 12,497 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novocol Pharmaceutical of Canada
Original FDA data
Every field from FDA enforcement report D-923-2013, exactly as published.
Show all FDA fields
- City
- Cambridge
- Status
- Terminated
- Country
- Canada
- Event ID
- 65979
- Address
- 25 Wolseley Court
- Code information
- Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-923-2013
- Classification
- Class II
- Recalling firm
- Novocol Pharmaceutical of Canada
- Product quantity
- 12,497 Boxes
- Termination date
- Jan 7, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- Aug 14, 2013
- Initial firm notification
- Center classification date
- Aug 26, 2013