Fluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination
Torrent Pharma Inc. is recalling Fluoxetine Tablets USP 20 mg due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit. The affected lot is distributed nationwide.
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: The FDA classified this as a Class II recall for a contamination issue (N-Nitroso Fluoxetine exceeding acceptable intake limits). No reported illnesses or injuries are stated in the source. The hazard involves potential carcinogenic impurity, which qualifies as a risk-of-harm product without reported adverse health events, supporting a score of 3 per the rubric.
Plain-English summary
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in 30-count bottles (NDC 13668-473-30, Lot# BDX6K001, expiration date 06/30/2025) manufactured by Torrent Pharmaceuticals Ltd. in India. The recall affects approximately 3,672 bottles distributed nationwide in the United States.
The recall is due to the presence of N-Nitroso Fluoxetine in the product that exceeds the interim acceptable intake limit established by the FDA. This represents a deviation from current good manufacturing practice (CGMP) standards.
Patients currently taking this medication should not stop taking their fluoxetine without consulting their healthcare provider. Consumers with this product should contact their pharmacy or healthcare provider regarding the recall. Healthcare providers and patients with questions may contact Torrent Pharma Inc. or the FDA for additional information.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Torrent Pharma Inc.
- Hazard
- n-nitroso-contamination
- cgmp-deviation
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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