Teligent Pharma is recalling Diclofenac Sodium Topical Solution 1.5% w/w 5 fl oz 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 of quality control issues. This recall affects products manufactured for SOLA Pharmaceuticals with specific batch numbers and expiration dates.
The recall is due to cGMP deviations, meaning the manufacturer discontinued its stability study program. This affects the product's quality but does not indicate immediate safety risks like injury or illness.
People who have the Diclofenac Sodium Topical Solution 1.5% w/w 5 fl oz bottles with batch numbers listed in the recall notice are affected. Those using prescription pain relief products are most at risk.
Check for Diclofenac Sodium Topical Solution 1.5% w/w 5 fl oz bottles with batch numbers 15384, 15646, 15971, 16206, 16226, 16268, 16342, 16343, 16503, 16504, 16632, 16715, or 16731. Products were manufactured for SOLA Pharmaceuticals and have specific expiration dates.
Identify the batch number and expiration date on the product label to confirm if it is in the recall list.
The product is being recalled due to cGMP deviations, as the manufacturer discontinued its stability study program.
The recall does not indicate a risk of injury; it is a quality control issue that does not affect safety.
Check the batch number and expiration date to see if it is in the recall list. If it is, contact the manufacturer for further 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-0680-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0680-2022 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.
