Hydrocortisone Butyrate Lotion recalled over manufacturing violations

Recall date

March 15, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teligent Pharma, Inc. recalls Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bot…

Recall number

D-0692-2022

FDA classification

Class II

Brand / firm

Teligent Pharma, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.