Lidocaine .01 mg/mL
Lidocaine Hydrochloride and Epinephrine Bitartrate · INJECTION, SOLUTION · Safco Dental Supply Co
Lidocaine with epinephrine is a local anesthetic injection used to numb tissue and reduce bleeding during dental and oral procedures. The medication works by blocking nerve signals in the area where it is injected.
Key Facts
- Brand Name
- Lidocaine
- Generic Name
- Lidocaine Hydrochloride and Epinephrine Bitartrate
- NDC Code (Product)
67239-0240- Manufacturer
- Safco Dental Supply Co
- Strength
- .01 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Marketing Status
- Application #
- ANDA088390
- Marketing Start
- 11/07/2011
Recall History
KRS Global Biotechnology, Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Akorn, Inc.
CGMP Deviations:
Pro Numb Tattoo Numbing Spray LLC
cGMP deviations
Teligent Pharma, Inc.
Superpotent Drug
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is Lidocaine used for?
Lidocaine with epinephrine is a local anesthetic injection used to numb tissue and reduce bleeding during dental and oral procedures. The medication works by blocking nerve signals in the area where it is injected.
Is Lidocaine a controlled substance?
Lidocaine is not classified as a controlled substance by the DEA.
What is the generic name for Lidocaine?
The generic name for Lidocaine is Lidocaine Hydrochloride and Epinephrine Bitartrate. There are 5 other brand versions of Lidocaine Hydrochloride and Epinephrine Bitartrate.
What is the NDC code for Lidocaine .01 mg/mL?
The NDC (National Drug Code) for Lidocaine .01 mg/mL is 67239-0240, listed by Safco Dental Supply Co.