Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Reported: August 23, 2017 Initiated: July 12, 2017 #D-1090-2017
Product Description
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Reason for Recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 101,952 15 mL unit dose cups
- Distribution
- Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014. Recalled by Akorn Inc. Units affected: 101,952 15 mL unit dose cups.
Why was this product recalled? ▼
Crystallization with subpotent out of specification assay results for chlorhexidine.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 23, 2017. Severity: Low. Recall number: D-1090-2017.
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