FDA recall D-0879-2022

Product

Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5

Reason for recall

Subpotent drug: Low OOS for menthol content at the three month room temperature.

Distribution

CA, ID, PA, OK

Key facts

Status

Terminated

Initiation date

2022-04-27

Report date

2022-05-25

Termination date

2024-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mooresville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0879-2022