FDA recall D-1089-2017

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

Reason for recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-07-12

Report date

2017-08-23

Termination date

2018-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2017