Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% tubes due to cGMP deviations. All recalled products were manufactured with discontinuing stability studies. No immediate harm reported.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% tubes because the company stopped its stability testing program. This means the product may not be safe for long-term use, but no injuries have been reported.
The recall is due to the manufacturer discontinuing its stability testing program, which means the product's quality and safety over time could be compromised. However, the product is not expected to cause immediate harm.
People who have the recalled Gentamicin Sulfate Cream USP 0.1% tubes (15g or 30g) for prescription use are affected. Those with medical conditions requiring this medication are at higher risk.
Check for 15g or 30g tubes labeled 'Gentamicin Sulfate Cream USP 0.1%' with NDC numbers 52565-085-15 or 52565-085-30. Prescription-only products were manufactured between 2022 and 2023.
Look for the NDC numbers 52565-085-15 or 52565-085-30 on the tube label.
The recall is due to the manufacturer stopping stability testing, but no injuries have been reported. The product may not be safe long-term.
The recall does not require immediate discontinuation, but you should check if you have the recalled tubes.
The official notice does not specify a remedy, so contact your healthcare provider for advice.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0686-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0686-2022 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.
