Teligent Pharma recalls 0.05% Clobetasol Propionate Cream due to cGMP deviations. Products manufactured for SOLA Pharmaceuticals 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 0.05% Clobetasol Propionate Cream in 60g tubes because the manufacturer discontinued its stability testing program. This recall affects prescription products with specific batch numbers and expiration dates.
The recall is due to cGMP deviations where the manufacturer stopped its stability testing program. This means the product's long-term safety and effectiveness could be compromised, but the immediate risk is low.
Prescription users of Clobetasol Propionate Cream 0.05% in 60g tubes. Those with the specific batch numbers and expiration dates listed in the recall are most at risk.
Check for the 60g tube packaging labeled 'Clobetasol Propionate Cream USP 0.05%'. Look for batch numbers 16001 (expiring 9/30/2022) or 16089 (expiring 11/30/2022).
Identify the batch number and expiration date on the tube packaging to confirm if it's affected.
The manufacturer discontinued its stability testing program, which is a cGMP deviation requiring the product to be recalled.
The product is safe for immediate use but the recall is due to the manufacturer stopping stability testing, which could affect long-term safety.
Check the batch number and expiration date to see if it's affected. If it is, contact the manufacturer for instructions.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0700-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0700-2022 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.
