Teligent Pharma recalls Econazole Nitrate Cream 1% tubes due to quality control issues. 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 Econazole Nitrate Cream 1% tubes because the company stopped its stability testing program. This means all products within their expiry dates are being recalled to ensure safety.
The recall is due to the company discontinuing its stability testing program, which means the product's safety over time wasn't verified. This could lead to potential quality issues, but the product is still safe for use within its expiry date.
People with prescriptions for Econazole Nitrate Cream 1% tubes from Teligent Pharma are affected. Those using the product for fungal infections are most at risk.
Check for Econazole Nitrate Cream 1% tubes labeled with NDC 52565-022-15 (15g), NDC 52565-022-85 (85g), or NDC 52565-022-30 (30g). The product is prescription-only and manufactured by Teligent Pharma in Buena, New Jersey.
Identify the product by checking the NDC code on the tube (52565-022-15, 52565-022-85, or 52565-022-30) and expiration date.
Yes, the product is safe for use within its expiration date, but it is being recalled because the manufacturer discontinued its stability testing program.
Teligent Pharma is recalling all Econazole Nitrate Cream 1% tubes because they stopped their stability testing program, which means the product's long-term safety wasn't verified.
No, the product is safe to use within its expiration date, but it is being recalled for quality control reasons.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0682-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0682-2022 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.