Home / Recalls / Upsher Smith Laboratories, Inc. / D-127-2013

D-127-2013 Class III Terminated

Recalled by Upsher Smith Laboratories, Inc. — Maple Grove, MN

Recall Details

Product Type
Drugs
Report Date
January 23, 2013
Initiation Date
December 10, 2012
Termination Date
November 19, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,316 bottles

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.

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 Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 310162, Exp 09/14

Other recalls by Upsher Smith Laboratories, Inc.

  • D-1836-2019 Class II — Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: (July 29, 2019)
  • D-0280-2019 Class II — Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upse (September 19, 2018)
  • D-0281-2019 Class II — Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upse (September 19, 2018)
  • D-1255-2014 Class III — Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured f (April 14, 2014)
  • D-160-2013 Class II — Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, R (November 20, 2012)