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
Product summary
- 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
Labeling: Missing