FDA-Drug2016-06-15Class II

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.

Aidarex Pharmaceuticals LLC
Hazard

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

Sold states
U.S. including: CA, ND, PA, TN
Affected count
292 Bottles
Manufactured in
595 N Smith Ave Ste B, N/A, Corona, CA, United States
Products
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.

Official notice

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

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