# FDA recall D-1402-2019

> **Synthetopes Inc** · Class II · drug recall initiated 2019-05-28.

## Product

Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

## Reason for recall

Lack of Processing Controls.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1402-2019
- **Recalling firm:** Synthetopes Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-06-19
- **Termination date:** 2020-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Conway, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1402-2019

## Citation

> AI Analytics. FDA recall D-1402-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1402-2019. Source: US FDA. Licensed CC0.

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