[pending] DULOXETINE (DULOXETINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0100-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 90-count- Lot # 240721C
- Exp. 02/28/2027 1000-count- Lot #230286C
- Exp.02/28/2026
Distribution
Distributed nationwide across the United States.
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