Drug Enforcement D-127-2013

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

Status

Terminated

Classification

Class III

Report Date

January 23, 2013

Termination Date

November 19, 2013

Product Information

Product description
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.
Product quantity
11,316 bottles
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.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Upsher Smith Laboratories, Inc.
Address
6701 Evenstad Drive, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-127-2013
Event ID
64085
Recall initiation date
December 10, 2012
Center classification date
January 16, 2013
Code info
Lot #: 310162, Exp 09/14
More code info
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