FDA recall D-127-2013

Product

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.

Reason for recall

Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-12-10

Report date

2013-01-23

Termination date

2013-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-127-2013