FDA recall D-0975-2016

Aidarex Pharmaceuticals LLC · Class II · drug

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.

Reason for recall

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

Distribution

U.S. including: CA, ND, PA, TN

Key facts

Status: Terminated
Initiation date: 2016-06-01
Report date: 2016-06-15
Termination date: 2016-10-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0975-2016