Teligent Pharma recalls 1.5% Diclofenac Sodium Topical Solution bottles due to cGMP deviations. All products within expiry are being recalled as the company discontinues its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Diclofenac Sodium Topical Solution 1.5% w/w 5 fl. oz. bottles because the company stopped its stability testing program. This recall affects products made between specific batches and expiration dates.
The recall is due to the company discontinuing its stability study program, which means the product's quality and safety could not be confirmed over time. This is a cGMP (current Good Manufacturing Practice) deviation, but it does not indicate immediate harm to users.
People with prescriptions for Diclofenac Sodium Topical Solution from Teligent Pharma. Those who have the specific batch numbers and expiration dates listed in the recall are most at risk.
Check for the product name 'Diclofenac Sodium Topical Solution USP 1.5% w/w', 5 fl. oz. bottle, and the specific batch numbers listed: 15066, 15389, 15437, 16823, 16825, 16826. The expiration dates are 3/31/2023, 12/31/2023, and 4/30/2024.
Identify the batch number and expiration date on the bottle to confirm if it is in the recalled list.
The company discontinued its stability study program, leading to cGMP deviations. All products within expiry are being recalled.
The recall is due to manufacturing quality concerns, not immediate safety risks. The product is safe to use but the company is discontinuing its stability testing.
Check for the batch numbers 15066, 15389, 15437, 16823, 16825, 16826 and expiration dates 3/31/2023, 12/31/2023, or 4/30/2024.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0679-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0679-2022 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.
