FDA recall D-0427-2019

Product

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.

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-0427-2019