# FDA recall D-050-2013

> **Stat Rx USA** · Class III · drug recall initiated 2012-06-18.

## Product

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

## Reason for recall

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

## Distribution

FL, PA, and VA.

## Key facts

- **Recall number:** D-050-2013
- **Recalling firm:** Stat Rx USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-18
- **Report date:** 2012-11-21
- **Termination date:** 2013-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-050-2013

## Citation

> AI Analytics. FDA recall D-050-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-050-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*