# FDA recall D-1311-2019

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

## Product

AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).

## 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-1311-2019
- **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-1311-2019

## Citation

> AI Analytics. FDA recall D-1311-2019. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/D-1311-2019. Source: US FDA. Licensed CC0.

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