FDA recall D-0817-2018

Product

Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02

Reason for recall

Failed Stability Specifications

Distribution

US Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-05-07

Report date

2018-05-23

Termination date

2018-12-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bronx, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0817-2018