Fluoxetine Tablets recall: CGMP Deviations
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for…
Why was Fluoxetine Tablets recalled?
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# BDX6K001; Exp. Date 06/30/2025
- Product
- Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for…
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- 3672 Bottles
- Distribution
- U.S. Nationwide.
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)