Lidocaine .01 mg/mL
Lidocaine Hydrochloride and Epinephrine Bitartrate · INJECTION, SOLUTION · Henry Schein Inc.
Lidocaine is a injection, solution containing lidocaine hydrochloride and epinephrine bitartrate at .01 mg/mL, taken submucosal. Manufactured by Henry Schein Inc..
Key Facts
- Brand Name
- Lidocaine
- Generic Name
- Lidocaine Hydrochloride and Epinephrine Bitartrate
- NDC Code (Product)
0404-6512- Manufacturer
- Henry Schein Inc.
- 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 contains Lidocaine Hydrochloride and Epinephrine Bitartrate. It is a injection, solution taken submucosal. Consult your doctor for specific uses.
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 0404-6512, listed by Henry Schein Inc..