# FDA recall D-0570-2022

> **Professional Disposables International, Inc.** · Class II · drug recall initiated 2022-02-04.

## Product

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY  10962-1376.

## Reason for recall

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

## Distribution

Product was distributed nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0570-2022
- **Recalling firm:** Professional Disposables International, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-04
- **Report date:** 2022-03-02
- **Termination date:** 2023-10-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2022

## Citation

> AI Analytics. FDA recall D-0570-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0570-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*