FDAFDA · Food and drugs·Recall number D-1255-2014
Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
Published April 30, 2014 · Recall initiated: April 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Upsher Smith Laboratories, Inc.
- Distributor
- Nationwide
- Lot
- Lot #2802.042A, Exp. 10/2015
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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