Diclofenac Sodium Topical Solution 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 Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceu…
- Recall number
- D-0680-2022
- 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
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
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