Teligent Pharma recalls Betamethasone Dipropionate Lotion 0.05% (Augmented) 30mL bottles due to failed stability testing. Product may not meet API particle specifications.
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Teligent Pharma is recalling Betamethasone Dipropionate Lotion 0.05% (Augmented) 30mL bottles because routine stability testing showed the active ingredient didn't meet particle specifications. This could mean the medication isn't stable or effective as intended.
The lotion failed stability testing for the active pharmaceutical ingredient particle count. This means the medication might not be stable or effective over time, potentially reducing its therapeutic benefit.
Prescription users of this specific lotion bottle. Patients with skin conditions requiring this medication are most at risk.
Check for the 30mL bottle labeled 'Betamethasone Dipropionate Lotion USP, 0.05% (Augmented)' with NDC 52565-023-29 and lot number 16569 (expiring 9/2022).
Verify the product label includes NDC 52565-023-29 and lot number 16569.
The recall states the product failed stability testing, but Teligent Pharma does not specify if it's unsafe for use. The product may not meet the required specifications.
Look for the 30mL bottle with NDC 52565-023-29 and lot number 16569 (expiring 9/2022).
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0297-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0297-2022 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.
