[pending] FLUOXETINE (FLUOXETINE)
Pending LLM rewrite. Source: FDA_DRUG D-0455-2025.
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: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Torrent Pharma 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# BDX6K001
- Exp. Date 06/30/2025
UPCs (2)
- 0313668443301
- 0313668473308
Distribution
Distributed nationwide across the United States.
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