FDA recall D-1088-2017

Product

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

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-1088-2017