# FDA recall D-0571-2022

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

## Product

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; 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-0571-2022
- **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-0571-2022

## Citation

> AI Analytics. FDA recall D-0571-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0571-2022. Source: US FDA. Licensed CC0.

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