Aidarex Pharmaceuticals LLC recalls CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILL
Recalled June 15, 2016 · FDA recall D-0975-2016 · Aidarex Pharmaceuticals
Hazard
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. · FDA Class II
Units
292 Bottles
Sold at
U.S. including: CA, ND, PA, TN
Description
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Product
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.
Manufacturer(s)
Aidarex Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →