Diflorasone Diacetate Ointment 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 Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Bato…
- Recall number
- D-0681-2022
- 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
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
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