# FDA recall D-1058-2019

> **Ingenus Pharmaceuticals Llc** · Class III · drug recall initiated 2019-03-18.

## Product

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL  32839-6408, NDC 50742-308-05.

## Reason for recall

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-1058-2019
- **Recalling firm:** Ingenus Pharmaceuticals Llc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-18
- **Report date:** 2019-04-03
- **Termination date:** 2020-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1058-2019

## Citation

> AI Analytics. FDA recall D-1058-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-1058-2019. Source: US FDA. Licensed CC0.

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