Why it was recalled
Failed Tablet/Capsule Specifications
Product description
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
Lot numbers, UPCs & expiration codes
Lot #: 02D163, Exp. 9/2017
Where it was sold
Nationwide and Puerto Rico
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-1449-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 18, 2016
- FDA report date
- Aug 3, 2016
- Quantity
- 14, 370 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1449-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74509
- Address
- 425 Privet Rd
- Code information
- Lot #: 02D163, Exp. 9/2017
- Postal code
- 19044-1220
- Report date
- Aug 3, 2016
- Product type
- Drugs
- Recall number
- D-1449-2016
- Classification
- Class III
- Recalling firm
- Teva North America
- Product quantity
- 14, 370 units
- Termination date
- Jan 17, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 27, 2016