Drug & medication recalls Moderate risk

Teligent Pharma, Inc. recalls Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, N…

Recall date
August 23, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0297-2022
FDA classification
Class II
Brand / firm
Teligent Pharma, Inc.
Sold / distributed
Distributed Nationwide in the USA

Why it was recalled

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

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), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

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