# FDA recall D-1041-2013

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

## Product

Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use 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/failed results were reported to customers as passing.  Hence the sterility of these products cannot be assured.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1041-2013
- **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-1041-2013

## Citation

> AI Analytics. FDA recall D-1041-2013. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1041-2013. Source: US FDA. Licensed CC0.

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