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- FDA Recall Duloxetine Delayed-release - NDC List
The most recent Recall Enforcement Report that covers this product was initiated on April 14th, 2025 and classified as a Class II recall due to cgmp deviations: presence of nitrosamine drug substance related impurity above the proposed interim limit This recall is currently ongoing, and the associated recall number is recall number is D-0387-2025
- Breckenridge Pharmaceutical, Inc. Duloxetine Delayed -Release Capsules . . .
The lots listed below are being recalled due to presence of Nitrosamine Drug Substance Related Impurity (NDSRJ), N-nitroso-duloxetine, above the proposed interim limit Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables Everyone is exposed to some level of nitrosamines
- FDA Recalls 233,000 Bottles of Duloxetine Over Risk of Cancerous Chemical
The FDA recalled over 233,000 bottles of duloxetine (Cymbalta; Eli Lilly Company), citing concerns over severe levels of nitrosamine drug substance impurity, N-nitroso-duloxetine, a known carcinogenic chemical
- FDA Announces Recall of More than 7000 Bottles of Duloxetine - Medscape
The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a
- Thousands of bottles of popular antidepressant recalled: 3 things to . . .
How do I know if my medication is impacted by the recall? The recall involves 7,101 bottles of duloxetine delayed-release capsules distributed nationwide within the United States, according to the FDA The recalled capsules are 20mg in strength, and sold in 500-count bottles
- DULOXETINE HYDROCHLORIDE Recall D-0161-2025
Description: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr by: Towa Pharmaceutical Europe, S L Martorelles, (Barcelona), Spain, Dist by: Breckenridge Pharmaceuticals, Inc , Berkeley Heights, NJ 07922
- Duloxetine antidepressant recall update as FDA sets risk class
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 and has been given the second highest risk classification by the FDA
- FDA Recall Duloxetine Capsule, Delayed Release Oral - NDC List
The most recent Recall Enforcement Report that covers this product was initiated on December 4th, 2024 and classified as a Class II recall due to cgmp deviations: the presence of a nitrosamine drug substance related impurity (ndsri), n-nitroso-duloxetine above the interim acceptable intake limit This recall is currently terminated, and the
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