Drug 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
D-1089-2017
Product summary
- Firm
- Akorn Inc
- Event
- Event 77822
- Status
- Terminated
- Classification
- Class III
- Quantity
- 40,978 unit dose cups
- Official record key
drug-enforcement:D-1089-2017
Official wording
Reason: Crystallization with subpotent out of specification assay results for chlorhexidine.
Code information: Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
subpotent