FDA-Drug2022-03-30Class II

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

Teligent Pharma, Inc.
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
6431 bottles
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief