FDA recall D-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.

Reason for recall

Failed Tablet/Capsule Specifications

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-05-18

Report date

2016-08-03

Termination date

2017-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1449-2016