Recalls / Class III
Class IIID-1449-2016
Product
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.
- Affected lot / code info
- Lot #: 02D163, Exp. 9/2017
Why it was recalled
Failed Tablet/Capsule Specifications
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 14, 370 units
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-05-18
- FDA classified
- 2016-07-27
- Posted by FDA
- 2016-08-03
- Terminated
- 2017-01-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1449-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.