Septodont recalls
FDA enforcement reports naming Septodont Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- May 29, 2019
- May 29, 2019Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridgesDrug · Septodont Inc.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 DENTAL. Xylocaine D…Class II
- May 16, 2018OraVerse (Phentolamine Mesylate) Injection, 0Drug · Septodont Inc.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 at the 15 month stab…Class III