# FDA recall D-1465-2016

> **Exact-Rx Inc** · Class III · drug recall initiated 2016-06-02.

## Product

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY

## Reason for recall

Crystallization; complaints received by the manufacturer of crystals forming in product

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1465-2016
- **Recalling firm:** Exact-Rx Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-02
- **Report date:** 2016-08-31
- **Termination date:** 2018-06-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1465-2016

## Citation

> AI Analytics. FDA recall D-1465-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1465-2016. Source: US FDA. Licensed CC0.

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