Drug & medication recalls Moderate risk

Teligent Pharma, Inc. recalls Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes,…

Recall date
May 14, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0636-2021
FDA classification
Class II
Brand / firm
Teligent Pharma, Inc.
Sold / distributed
Nationwide in the United States

Why it was recalled

Presence of Foreign Substance: Foreign particles observed during 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

Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.

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