FDA recall D-0611-2018

Product

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.

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-0611-2018