Why it was recalled
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Product description
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
Lot numbers, UPCs & expiration codes
Lot # 39C192, exp 06/2019
Where it was sold
Nationwide
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-0096-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2017
- FDA report date
- Dec 6, 2017
- Quantity
- 3,870 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0096-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78552
- Address
- 1090 Horsham Rd
- Code information
- Lot # 39C192, exp 06/2019
- Postal code
- 19454-1505
- Report date
- Dec 6, 2017
- Product type
- Drugs
- Recall number
- D-0096-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 3,870 bottles
- Termination date
- Jul 3, 2018
- Reason for recall
- Failed Tablet/Capsule Specifications; potential presence of broken tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 9, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 27, 2017