Teligent Pharma recalls 0.05% Fluocinonide Gel tubes due to cGMP deviations. All products within expiry are being recalled 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 0.05% Fluocinonide Gel in 15g, 30g, and 60g tubes because the company stopped its stability testing program. This recall affects all products within their expiry dates.
The recall is due to the manufacturer discontinuing its stability study program, which means the product's safety and effectiveness could be compromised over time. However, the products are still safe for use within their expiry dates.
Prescription users of Fluocinonide Gel 0.05% in 15g, 30g, or 60g tubes. People with skin conditions requiring topical corticosteroids are most at risk.
Check for 15g, 30g, or 60g tubes labeled with NDC 52565-054-15, 52565-054-30, or 52565-054-60. The product is prescription-only and has specific batch numbers and expiry dates.
Look for the NDC codes 52565-054-15, 52565-054-30, or 52565-054-60 on the tube packaging.
Yes, the product is safe for use within its expiry date, but it is being recalled due to the manufacturer discontinuing stability testing.
Teligent Pharma is recalling all products because they discontinued their stability study program, which could affect long-term safety and effectiveness.
No, the product is safe within its expiry date, but the manufacturer is recalling it due to the stability program discontinuation.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0684-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0684-2022 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.
