Septodont Inc.
Septodont Inc. lists 15 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 0362-0753 | Carbocaine Injection, Solution | Mepivacaine Hydrochloride 30 mg/mL | Rx |
| 0362-3971 | DycloPro Solution | Dyclonine Hydrochloride 5 mg/mL | Rx |
| 0362-1200 | Flavalta Injection, Solution | Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate .01 mg/mL | Rx |
| 0362-0221 | Lidocaine Ointment | Lidocaine 5 g/100g | Rx |
| 0362-0262 | Lidocaine Injection, Solution | Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate .02 mg/mL | Rx |
| 0362-0898 | Lidocaine Injection, Solution | Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate .01 mg/mL | Rx |
| 0362-1096 | Lignospan Forte Injection, Solution | Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate .02 mg/mL | Rx |
| 0362-1095 | Lignospan Standard Injection, Solution | Lidocaine Hydrochloride 20 mg/mL; Epinephrine Bitartrate .01 mg/mL | Rx |
| 0362-0557 | Marcaine Injection, Solution | Bupivacaine Hydrochloride Anhydrous 5 mg/mL; Epinephrine Bitartrate .005 mg/mL | Rx |
| 0362-0101 | Oraverse Injection, Solution | Phentolamine Mesylate .235 mg/mL | Rx |
| 0362-1098 | Scandonest 3% Plain Injection, Solution | Mepivacaine Hydrochloride 30 mg/mL | Rx |
| 0362-9048 | Septocaine and Epinephrine Injection, Solution | Articaine Hydrochloride 40 mg/mL; Epinephrine Bitartrate .005 mg/mL | Rx |
| 0362-9049 | Septocaine and Epinephrine Injection, Solution | Articaine Hydrochloride 40 mg/mL; Epinephrine Bitartrate .01 mg/mL | Rx |
| 0362-9011 | Vivacaine Injection, Solution | Bupivacaine Hydrochloride Anhydrous 5 mg/mL; Epinephrine Bitartrate .005 mg/mL | Rx |
| 0362-0830 | Zorcaine Injection, Solution | Articaine Hydrochloride 40 mg/mL; Epinephrine Bitartrate .01 mg/mL | Rx |
Recalls by Septodont Inc.
- D-1307-2019 May 29, 2019 · Class II
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent… - D-0828-2018 May 16, 2018 · Class III
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity…