Reported Apr 30, 2014 · Terminated

Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN…

Upsher Smith Laboratories, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Upsher Smith Laboratories, Inc. · 6701 Evenstad Drive · Maple Grove, MN · 55369

Is this the product you have?

  • Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle
  • Manufactured forUpsher-Smith Labs, Minneapolis, MN 55447
  • byPharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
Lot codes and dates
    • Lot #2802.042A
    • Exp. 10/2015
Amount recalled
1,185 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 1, 2014 · Data as of Sep 19, 7:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.