Drug product
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
D-1090-2017
Product summary
- Firm
- Akorn Inc
- Event
- Event 77822
- Status
- Terminated
- Classification
- Class III
- Quantity
- 101,952 15 mL unit dose cups
- Official record key
drug-enforcement:D-1090-2017
Official wording
Reason: Crystallization with subpotent out of specification assay results for chlorhexidine.
Code information: 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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
subpotent