Why it was recalled
Failed Dissolution Specifications: low test results at the 18 month time-point
Product description
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
Lot numbers, UPCs & expiration codes
Lot # 3A404012V, Exp. 4/2016
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-0732-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 21, 2015
- FDA report date
- Mar 9, 2016
- Quantity
- 1,895 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-0732-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 72912
- Address
- 425 Privet Rd
- Code information
- Lot # 3A404012V, Exp. 4/2016
- Postal code
- 19044-1220
- Report date
- Mar 9, 2016
- Product type
- Drugs
- Recall number
- D-0732-2016
- Classification
- Class II
- Recalling firm
- Teva North America
- Product quantity
- 1,895 bottles
- Termination date
- Jan 13, 2017
- Reason for recall
- Failed Dissolution Specifications: low test results at the 18 month time-point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 21, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2016