Preferred Pharmaceuticals recalls 30mg Duloxetine bottles due to potential N-nitroso impurity above FDA limits. This may pose health risks. Consumers should contact the company for details.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Preferred Pharmaceuticals is recalling Duloxetine Delayed-Release Cap USP 30mg bottles because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose health risks to people taking the medication.
The recall is due to the presence of N-nitroso-duloxetine impurities in the medication. This impurity exceeds the FDA's recommended safety limits and could potentially cause health issues when taken.
People who have been prescribed Duloxetine Delayed-Release Cap USP 30mg bottles with NDC 68788-9301-03 are affected. Those taking this medication for depression or other conditions are at risk.
Check for the product name 'Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only' with NDC 68788-9301-03. The lot number J2022G and expiration date 01/01/2025 are also on the label.
Reach out to Preferred Pharmaceuticals for specific instructions on handling the recalled product.
The recall indicates the medication contains an impurity above FDA safety limits, so it is not safe to take.
Look for the NDC 68788-9301-03 label on the bottle, which has the lot number J2022G and expires 01/01/2025.
Contact Preferred Pharmaceuticals directly for instructions on what to do with the product.
We’ve drafted a message you can send Preferred Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0505-2024 — Preferred Pharmaceuticals Preferred Pharmaceuticals Hello, I own a Preferred Pharmaceuticals that is covered by recall D-0505-2024 from Preferred Pharmaceuticals. 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.
