Fluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in a 28-count carton due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a known impurity (N-Nitroso Fluoxetine) exceeding acceptable limits. Although no illnesses have been reported, the source does not state that no harm has been reported; the presence of an impurity exceeding interim acceptable intake limits in a widely distributed psychiatric medication meets the Severe threshold under the rubric for Class II drug recalls.
Plain-English summary
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg (NDC: 13668-473-91 for carton; 13668-473-70 for blister) due to CGMP deviations involving the presence of N-Nitroso Fluoxetine that exceeds the interim acceptable intake limit.
The affected product is a 28-count carton in a 4x7 unit-dose configuration manufactured by Torrent Pharmaceuticals Ltd. in Indrad, India, for Torrent Pharma Inc., Basking Ridge, New Jersey. The recall involves Lot# BDX6K001 with an expiration date of 06/30/2025, totaling 972 cartons distributed nationwide in the United States.
Patients currently taking this medication should not stop taking it without consulting their healthcare provider. Patients should contact their healthcare provider or pharmacist regarding this recall and disposal of any affected product they may have.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Torrent Pharma Inc.
- Hazard
- n-nitroso-impurity
- 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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