Teligent Pharma recalls Halobetasol Propionate Ointment 0.05% tubes due to manufacturing quality issues. 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 Halobetasol Propionate Ointment 0.05% tubes (50g) because the manufacturer discontinued its stability study program. This recall affects all products within their expiration dates.
The recall is due to the manufacturer discontinuing its stability study program, which means the product's long-term safety and effectiveness cannot be confirmed. This is a quality control issue related to manufacturing processes, not an immediate safety hazard.
Prescription users of Halobetasol Propionate Ointment 0.05% 50g tubes. Patients with specific medical conditions requiring this medication are most at risk.
Check for the product name 'Halobetasol Propionate Ointment 0.05% 50g tube', prescription-only, and the batch numbers listed in the recall notice. The expiration dates range from February 2022 to July 2023.
Verify the product name, batch number, and expiration date on the tube to confirm if it is recalled.
The recall is due to the manufacturer discontinuing stability testing, not an immediate safety hazard. The product is safe for use until the expiration date, but the recall is for quality assurance.
Check the batch number and expiration date on the tube. Recalled batches include 15128 (exp. 2/28/2022), 15721 (exp. 6/30/2022), 16171 (exp. 10/31/2022), 16819 (exp. 4/30/2023), and 17124 (exp. 7/31/2023).
No, the recall does not require stopping use. The product is safe for use until expiration, but the manufacturer is discontinuing stability testing for quality assurance.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0688-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0688-2022 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.
