Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Read the official notice →- Date
- 2024-10-23
- Country
- United States
- Brand
- Breckenridge Pharmaceutical
- Product
- Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI,…
- Classification
- Class II
- Units
- Product was distributed nationwide within the United States
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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- 2025-04-09
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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