FDA recall D-0690-2022

Product

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2022-03-15

Report date

2022-03-30

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0690-2022