Septodont Gmbh

11 FDA enforcement records linked to this company.

• recall — Class II2019-05-29

  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 DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.

• recall — Class III2018-05-16

  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 stability test point.

• 4832017-11-22

  Procedure Deviations Recorded and Justified

• 4832017-11-22

  Adequate lab facilities not available

• 4832017-11-22

  Strict control not exercised over labeling issued

• 4832013-06-12

  Procedure Deviations Recorded and Justified

• 4832013-06-12

  Procedures not in writing, fully followed

• 4832013-06-12

  Equipment for Environmental Control

• 4832013-06-12

  Review of representative number of batches

• 4832013-06-12

  Adequate lab facilities not available

• 4832013-06-12

  Authority lacking to review records, investigate errors