Teligent Pharma recalls 0.1% Hydrocortisone Butyrate Lotion due to cGMP deviations. Products with specific NDCs and expiration dates are affected. No remedy provided in official notice.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling 0.1% Hydrocortisone Butyrate Lotion bottles that were manufactured with cGMP deviations. This recall is due to the company discontinuing its stability study program, which means the product's quality may not be as expected.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the product was made without following proper quality control procedures. The company has stopped its stability testing program, so there's uncertainty about the product's safety and effectiveness over time.
People who have the recalled lot numbers of Hydrocortisone Butyrate Lotion (0.1%, 2 fl oz or 4 fl oz bottles) are affected. Those using prescription-strength corticosteroid creams for skin conditions are most at risk.
Check for 2 fl oz (59 mL) bottles with NDC 52565-087-02 or 4 fl oz (118 mL) bottles with NDC 52565-087-04. Products were manufactured with specific batch numbers and expiration dates listed in the recall notice.
Identify the product by checking the NDC code (52565-087-02 or 52565-087-04) and expiration date on the label.
The recall is due to cGMP deviations, as the manufacturer discontinued its stability study program, which affects the product's quality and safety.
The official notice does not provide a remedy; the product is being recalled due to manufacturing issues, but no specific action is required beyond checking the product details.
The recall notice does not specify a remedy, so you should check the product details and contact the manufacturer if you have concerns.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0692-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0692-2022 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.
