Recalls / Class III
Class IIID-1255-2014
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
- Affected lot / code info
- Lot #2802.042A, Exp. 10/2015
Why it was recalled
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.
Recalling firm
- Firm
- Upsher Smith Laboratories, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6701 Evenstad Drive, N/A, Maple Grove, Minnesota 55369
Distribution
- Quantity
- 1,185 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-14
- FDA classified
- 2014-04-23
- Posted by FDA
- 2014-04-30
- Terminated
- 2014-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1255-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.