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FDAFDA · Food and drugs·Recall number D-0297-2022

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

Published January 5, 2022 · Recall initiated: August 23, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Teligent Pharma, Inc.
Distributor
Distributed Nationwide in the USA
Lot
Lot # 16569, Exp 9/2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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