FDA recall D-0425-2019

Product

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22

Reason for recall

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-12-07

Report date

2019-02-13

Termination date

2023-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belleville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2019