Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Recall notice
Crystallization with subpotent out of specification assay results for chlorhexidine.
Contact the company & request your remedy
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Source Page by GovInfoNow · govinfonow.com/recall/41505-akorn-inc-recalls-halyard-24-hour-oral-care-kit-q2 · Recall date July 12, 2017 · FDA enforcement record: FDA #D-1089-2017
Cite this page
“Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse..” GovInfoNow, recall dated July 12, 2017. https://govinfonow.com/recall/41505-akorn-inc-recalls-halyard-24-hour-oral-care-kit-q2. Based on FDA recall #D-1089-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1089-2017%22&limit=1).
How to tell if you have this one
- Brand
Akorn, Inc.- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1088-2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.; Lot: 353394, Exp 10-2018 | 541,900 unit dose cups (5,419 trays) |
| D-1089-2017 | Halyard 24-Hour Oral Care Kit q2, 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 # 97012; Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018. | 40,978 unit dose cups |
| D-1090-2017 | 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; Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018. | 101,952 15 mL unit dose cups |
Contact Akorn, Inc.
We’ve drafted a message you can send Akorn, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1089-2017 — Akorn, Inc. Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.1 Hello, I own a Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. that is covered by recall D-1089-2017 from Akorn, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1089-2017 (July 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1089-2017 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.