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Recall Observatory FDA recall evidence

Drug product

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

D-1255-2014

April 14, 2014

Class III

Product summary

Firm
Upsher Smith Laboratories, Inc.
Event
Event 68049
Status
Terminated
Classification
Class III
Quantity
1,185 bottles
Official record key
drug-enforcement:D-1255-2014

Official wording

Reason: 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.

Code information: Lot #2802.042A, Exp. 10/2015

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing