Teligent Pharma recalls 0.1% Hydrocortisone Butyrate Lotion due to cGMP deviations. Products manufactured for SOLA Pharmaceuticals are being discontinued after stability testing.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion (0.1%, 4 fl oz) because of manufacturing quality issues. This recall affects products made for SOLA Pharmaceuticals that were discontinued after stability testing was halted.
The recall is due to the manufacturer discontinuing its stability testing program, which means the product's quality and safety could not be confirmed before the expiration date. This is a quality control issue, not a direct safety hazard like injury or fire.
Prescription users of the Hydrocortisone Butyrate Lotion who received products manufactured for SOLA Pharmaceuticals. Those with the specific batch numbers and expiration date are most at risk.
Check for the product name 'Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL)', manufactured for SOLA Pharmaceuticals, with batch numbers 16896 or 16897, and expiration date 5/31/2023.
Look for the batch numbers 16896 or 16897 and expiration date 5/31/2023 on the product label.
The manufacturer discontinued its stability testing program, so the product's quality and safety could not be confirmed before the expiration date.
This recall is due to quality control issues, not a direct safety hazard like injury or fire. The product is safe to use but being recalled for quality reasons.
Check the product label for batch numbers 16896 or 16897 and expiration date 5/31/2023. If it matches, contact Teligent Pharma 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-0703-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0703-2022 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.
