FDA recall D-0452-2023

Product

Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756

Reason for recall

CGMP DEVIATIONS

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-02-24

Report date

2023-03-15

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2023