# FDA recall D-1316-2019

> **Inopak Ltd** · Class II · drug recall initiated 2019-04-22.

## Product

Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ  07456.

## Reason for recall

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1316-2019
- **Recalling firm:** Inopak Ltd
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-22
- **Report date:** 2019-06-05
- **Termination date:** 2024-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ringwood, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1316-2019

## Citation

> AI Analytics. FDA recall D-1316-2019. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-1316-2019. Source: US FDA. Licensed CC0.

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