Why it was recalled
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Product description
CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96
Lot numbers, UPCs & expiration codes
Lot # 32900136A, Exp. 05/14
Where it was sold
NC
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-237-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2013
- FDA report date
- Apr 10, 2013
- Quantity
- 3 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-237-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64305
- Address
- 650 Cathill Rd
- Code information
- Lot # 32900136A, Exp. 05/14
- Postal code
- 18960-1512
- Report date
- Apr 10, 2013
- Product type
- Drugs
- Recall number
- D-237-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 3 boxes
- Termination date
- Jan 15, 2014
- Reason for recall
- Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96
- Distribution pattern
- NC
- Recall initiation date
- Feb 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2013