Why it was recalled
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Product description
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Distributed throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0578-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 5, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 1,157,095 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0578-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 79118
- Address
- 1090 Horsham Rd
- Code information
- All lots within expiry.
- Postal code
- 19454-1505
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0578-2018
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 1,157,095 bottles
- Termination date
- Apr 30, 2019
- Reason for recall
- Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
- Distribution pattern
- Distributed throughout the United States
- Recall initiation date
- Feb 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2018