Teligent Pharma recalls Desoximetasone Ointment 0.05% tubes due to cGMP deviations. All products within expiry are being recalled as the manufacturer 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 Desoximetasone Ointment 0.05% tubes (100g) because the manufacturer discontinued its stability study program. This recall affects products made in batches 15996 and 15997 that expired by September 30, 2022.
The recall is due to the manufacturer discontinuing its stability study program, which means the product's quality and safety could not be verified over time. This is a cGMP (current Good Manufacturing Practice) deviation, but it does not indicate an immediate risk of injury.
Prescription patients who received Desoximetasone Ointment 0.05% tubes from Teligent Pharma. The risk is low as the product is not expected to cause injury.
Check for Desoximetasone Ointment USP 0.05% tubes (100g) with NDC 70512-037-10. Products were manufactured in batches 15996 or 15997 and expired by September 30, 2022.
Verify the product's NDC number (70512-037-10), batch numbers (15996 or 15997), and expiration date (by September 30, 2022).
The manufacturer discontinued its stability study program, which is a cGMP deviation. This means the product's quality and safety could not be verified over time.
No, the recall is for quality assurance reasons, not due to an immediate safety hazard.
Check for Desoximetasone Ointment USP 0.05% tubes with NDC 70512-037-10, batch numbers 15996 or 15997, and expiration by September 30, 2022.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0676-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0676-2022 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.