# FDA recall D-1315-2019

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

## Product

Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY  10566

## 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-1315-2019
- **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-1315-2019

## Citation

> AI Analytics. FDA recall D-1315-2019. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-1315-2019. Source: US FDA. Licensed CC0.

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