Reported Aug 23, 2017 · Terminated
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse.…
Akorn Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn Inc · 1925 W Field Ct · Lake Forest, IL · 60045-4862
Is this the product you have?
- 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
- Lot codes and dates
- Lots
02026350720202635073EXP 06-201802026302050202630206EXP 07-20180202630203020263020402026422170202642218020264221902026474100202647411EXP 08-20180202647409020264741202026534310202653432EXP 09-2018
- Lots
- Amount recalled
- 101,952 15 mL unit dose cups
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Crystallization with subpotent out of specification assay results for chlorhexidine.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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