Recalls / Class III
Class IIID-0612-2018
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.
- Affected lot / code info
- 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
Why it was recalled
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 48,176 unit dose cups
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-03-29
- FDA classified
- 2018-03-29
- Posted by FDA
- 2018-04-04
- Terminated
- 2020-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0612-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.