FDA recall D-0613-2018

Product

24-HOUR Oral Care q4 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 97014.

Reason for recall

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-03-29

Report date

2018-04-04

Termination date

2020-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2018