Betamethasone Dipropionate Lotion USP 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 Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b…

Recall number

D-0669-2022

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

Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310