Recalls / Class III
Class IIID-1089-2017
Product
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
- Affected lot / code info
- Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.
Why it was recalled
Crystallization with subpotent out of specification assay results for chlorhexidine.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 40,978 unit dose cups
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-07-12
- FDA classified
- 2017-08-14
- Posted by FDA
- 2017-08-23
- Terminated
- 2018-06-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1089-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.