Teligent Pharma recalls Clobetasol Propionate Cream USP 0.05% 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 all Clobetasol Propionate Cream USP 0.05% products because the company stopped its stability testing program, which could affect product safety. This recall affects prescription-strength topical corticosteroid creams sold in various sizes.
The recall is due to the manufacturer discontinuing its stability testing program, which means the product's safety and effectiveness over time could be compromised. This is a manufacturing quality issue, not a direct hazard like injury or fire.
Prescription users of Clobetasol Propionate Cream USP 0.05% for skin conditions. People with sensitive skin or long-term use may be at higher risk due to potential stability issues.
Check for the product name 'Clobetasol Propionate Cream USP 0.05%' in tubes labeled with NDC numbers 52565-051-15 (15g), 52565-051-30 (30g), 52565-051-45 (45g), or 52565-051-60 (60g). The product is prescription-only and manufactured by Teligent Pharma in Buena, NJ.
Identify the NDC number on the tube to confirm if it's part of the recall (52565-051-15, 52565-051-30, 52565-051-45, or 52565-051-60).
The recall is due to the manufacturer discontinuing stability testing, not an immediate safety hazard. The product may still be safe but the company is recalling it to ensure long-term quality.
The recall record does not specify a return process or disposal instructions.
The manufacturer is discontinuing its stability testing program, so the product is being recalled to ensure safety over time, but no specific action is required beyond checking the NDC number.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0670-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0670-2022 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.
