Aidarex Pharmaceuticals LLC recalls CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILL…
- Recall date
- June 1, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0975-2016
- FDA classification
- Class II
- Brand / firm
- Aidarex Pharmaceuticals LLC
- Sold / distributed
- U.S. including: CA, ND, PA, TN
Why it was recalled
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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