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.
Reported: June 15, 2016 Initiated: June 1, 2016 #D-0975-2016
Product Description
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.
Details
- Recalling Firm
- Aidarex Pharmaceuticals LLC
- Units Affected
- 292 Bottles
- Distribution
- U.S. including: CA, ND, PA, TN
- Location
- Corona, CA
Frequently Asked Questions
What product 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.. Recalled by Aidarex Pharmaceuticals LLC. Units affected: 292 Bottles.
Why was this product recalled? ▼
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2016. Severity: Moderate. Recall number: D-0975-2016.
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