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.
Drug Recall
Official source record
- Recall number
- D-923-2013
- Event ID
- 65979
- Classification
- Class II
- Status
- Terminated
- Recalling company
- Novocol Pharmaceutical of Canada
- 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.
- Report date
- September 4, 2013
- Recall initiation date
- August 14, 2013
- Termination date
- January 7, 2014
- Distribution pattern
- Nationwide and Canada
Drug product identifiers
- Manufacturer
- Darby Dental Supply, LLC
- Brand name
- LIDOCAINE
- Generic name
- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
- Substance names
- EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
- Product NDC
- 66467-9730
- Package NDCs
- 0362-9023-05; 42756-1030-5; 66467-9730-5
- Route
- SUBMUCOSAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
