CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

Recall Number: D-0975-2016

Firm: Aidarex Pharmaceuticals LLC

Classification: Class II

Status: Terminated

Report Date: 20160615

Initiation Date: 20160601

Termination Date: 20161014

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.