Why it was recalled
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Product description
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Lot numbers, UPCs & expiration codes
Lot #: 34034024B, Exp 02/20
Where it was sold
Distributed nationwide in the USA
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-0001-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2018
- FDA report date
- Oct 10, 2018
- Quantity
- 313 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0001-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81068
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 34034024B, Exp 02/20
- Postal code
- 19454-1505
- Report date
- Oct 10, 2018
- Product type
- Drugs
- Recall number
- D-0001-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 313 bottles
- Termination date
- May 1, 2019
- Reason for recall
- Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
- Distribution pattern
- Distributed nationwide in the USA
- Recall initiation date
- Sep 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2018