Desonide Ointment 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 Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufa…
- Recall number
- D-0675-2022
- 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
Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
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