Teligent Pharma recalls 60g Diflorasone Diacetate Ointment tubes due to cGMP deviations in stability testing. All products within expiry are affected as the manufacturer discontinues stability studies.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Diflorasone Diacetate Ointment 0.05% tubes because of cGMP deviations in stability testing. This means the product may not be safe for use as the manufacturer has stopped its stability study program.
The product was recalled due to cGMP deviations in stability testing. The manufacturer discontinued its stability study program, meaning the product's safety over time could be compromised.
People with prescriptions for Diflorasone Diacetate Ointment 0.05% 60g tubes from Teligent Pharma or SOLA Pharmaceuticals. Those using the product for skin conditions are most at risk.
Check for Diflorasone Diacetate Ointment USP 0.05% 60g tubes with NDC 70512-031-60. Look for batch numbers 15800, 15876, 15904, 15917, 15922 (expiring 7/31/2022 or 8/31/2022) or 16202, 16203 (expiring 11/30/2022).
Identify the batch number and expiration date on the tube to confirm if it's part of the recall.
The manufacturer has recalled all products due to cGMP deviations in stability testing, so it is not safe for use as the stability study program was discontinued.
Check for Diflorasone Diacetate Ointment USP 0.05% 60g tubes with NDC 70512-031-60 and batch numbers listed in the recall notice.
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe disposal or alternative treatments.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0681-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0681-2022 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.
