[pending] DULOXETINE (DULOXETINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0621-2025.
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 proposed interim limit.
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 (2)
- Lot 240927C
- Exp 04/30/2027
Distribution
Distributed in 3 states:
- AZ
- IN
- NJ
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