Drug product
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
D-0612-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 79635
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48,176 unit dose cups
- Official record key
drug-enforcement:D-0612-2018
Official wording
Reason: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Code information: Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202511399, 0202511400, 0202543553, Exp 03/18; 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225, Exp 04/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent