drugs Class III Updated 2014-04-30

Upsher Smith Laboratories, Inc. recalls Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bo

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #2802.042A, Exp. 10/2015
View official government recall

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