Teligent Pharma recalls 0.05% Betamethasone Dipropionate Lotion due to cGMP deviations. All products within expiry 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 Betamethasone Dipropionate Lotion 0.05% (Augmented) products because the company stopped its stability testing program. This recall affects all bottles within their expiry dates, but the product itself is not unsafe for use.
The recall is due to the manufacturer discontinuing its stability study program, which means the product's long-term safety and effectiveness cannot be confirmed. However, the product is not considered unsafe for immediate use.
People who own or use the recalled Betamethasone Dipropionate Lotion 0.05% (Augmented) products. Those most at risk are individuals using the product for medical purposes.
Check for 30 mL or 60 mL bottles labeled 'Betamethasone Dipropionate Lotion USP, 0.05% (Augmented)' with NDC numbers 52565-023-29 or 52565-023-59. The products were sold with specific batch numbers and expiry dates.
Identify the product by checking the NDC numbers (52565-023-29 or 52565-023-59) and batch numbers listed in the recall notice.
The product is not unsafe for immediate use, but the manufacturer has stopped its stability testing program, so long-term safety cannot be confirmed.
The recall is due to the manufacturer discontinuing its stability study program, which means the product's long-term safety and effectiveness cannot be confirmed.
No, the product is not unsafe for immediate use, but the manufacturer is recalling all products within expiry dates due to the stability program discontinuation.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0669-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0669-2022 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.
