# FDA recall D-0393-2016

> **Geritrex Corp** · Class II · drug recall initiated 2015-10-27.

## Product

Polyethylene Glycol 3350-GRX Powder 100% jars a)  8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz  (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550

## Reason for recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0393-2016
- **Recalling firm:** Geritrex Corp
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-27
- **Report date:** 2015-12-09
- **Termination date:** 2018-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mount Vernon, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2016

## Citation

> AI Analytics. FDA recall D-0393-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0393-2016. Source: US FDA. Licensed CC0.

---

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