Prevantics — Class II drug recall D-0570-2022
Terminated recall by Professional Disposables International, Inc., reported 2022-03-02, distributed nationwide. cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the pro
| Recall number | D-0570-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Professional Disposables International, Inc., Orangeburg, NY, United States |
| Recall initiated | 2022-02-04 |
| Classified | 2022-02-18 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2023-10-31 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 10819-4076, 10819-4076-03, 10819-4076-04 |
| Expiration dates | 2022-02-20, 2022-03-20, 2022-06-20, 2022-07-20, 2022-08-20, 2022-09-20, 2022-10-20, 2022-12-20, 2023-01-20, 2023-02-20, 2023-03-20, 2023-04-20, 2023-05-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0570-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.