FDA recall D-0054-2021

Product

Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15

Reason for recall

SUBPOTENT DRUG

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-07-13

Report date

2020-11-04

Termination date

2022-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0054-2021