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FLUOXETINE
Wed Jun 11 2025
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Manufacturers
| Drug | Manufacturer |
|---|---|
| FLUOXETINE | Torrent Pharmaceuticals Limited |
Number of affected units
3672 Bottles
Distribution pattern
U.S. Nationwide.
UPCs
| UPC |
|---|
| 0313668443301 |
| 0313668473308 |
Package NDCs
| NDC |
|---|
| 13668-443-74 |
| 13668-443-10 |
| 13668-443-01 |
| 13668-443-30 |
| 13668-443-91 |
| 13668-473-10 |
| 13668-473-74 |
| 13668-473-30 |
| 13668-473-01 |
| 13668-473-91 |
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