Teligent Pharma is recalling Fluocinonide Cream USP 0.1% 120g tubes due to cGMP deviations. All products within expiry are affected as the company discontinues stability testing.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling fluocinonide cream tubes that were made without proper stability testing. This means the product may not be safe for long-term use even if it hasn't expired.
The manufacturer stopped its stability testing program, which means the product's quality and safety over time could be compromised. However, the recall does not indicate immediate harm or injury risks.
People with prescriptions for fluocinonide cream who received the recalled tubes from Teligent Pharma in New Jersey. Those using the product for extended periods may face reduced effectiveness.
Check for the product name 'Fluocinonide Cream USP 0.1% 120 grams tube' with the manufacturer Teligent Pharma, Inc. from New Jersey. Look for batch numbers 15288, 16065, 16430, 16431, or 16675.
Identify the batch number and expiration date on the tube to confirm if it's recalled.
The recall states cGMP deviations but does not mention immediate injury risks. The product may not be safe for long-term use.
The recall does not require stopping use immediately; it's a quality issue that may affect long-term effectiveness.
Check the batch number on the tube: 15288, 16065, 16430, 16431, or 16675.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0683-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0683-2022 from Teligent Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.