# FDA recall D-1255-2014

> **Upsher Smith Laboratories, Inc.** · Class III · drug recall initiated 2014-04-14.

## 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

## 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

## Key facts

- **Recall number:** D-1255-2014
- **Recalling firm:** Upsher Smith Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-14
- **Report date:** 2014-04-30
- **Termination date:** 2014-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1255-2014

## Citation

> AI Analytics. FDA recall D-1255-2014. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1255-2014. Source: US FDA. Licensed CC0.

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