D-1255-2014 Class III Terminated
FDA drug recall D-1255-2014 was initiated by Upsher Smith Laboratories, Inc. on April 14, 2014 and is designated Class III. 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, … The recall status is terminated (terminated July 1, 2014). Affected quantity: 1,185 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- April 14, 2014
- Termination Date
- July 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,185 bottles
Product Description
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
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 Pattern
Nationwide
Code Information
Lot #2802.042A, Exp. 10/2015