# FDA recall D-1039-2013

> **Leiter's Pharmacy** · Class II · drug recall initiated 2013-08-26.

## Product

Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

## Reason for recall

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing.  Hence the sterility of these products cannot be assured.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1039-2013
- **Recalling firm:** Leiter's Pharmacy
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-26
- **Report date:** 2013-09-25
- **Termination date:** 2014-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1039-2013

## Citation

> AI Analytics. FDA recall D-1039-2013. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1039-2013. Source: US FDA. Licensed CC0.

---

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