Class III
Terminated
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
- Company
- Upsher Smith Laboratories, Inc.
- Recall Initiated
- April 14, 2014
- Posted
- April 30, 2014
- Recall Number
- D-1255-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,185 bottles
- Firm Location
- Maple Grove, MN, United States
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot #2802.042A, Exp. 10/2015
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