# FDA recall D-0013-2017

> **Leiter's Compounding** · Class II · drug recall initiated 2016-09-20.

## Product

Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38

## Reason for recall

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0013-2017
- **Recalling firm:** Leiter's Compounding
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-20
- **Report date:** 2016-10-19
- **Termination date:** 2017-05-03

- **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-0013-2017

## Citation

> AI Analytics. FDA recall D-0013-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0013-2017. Source: US FDA. Licensed CC0.

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