Prevantics — Class II drug recall D-0572-2022
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-0572-2022 |
|---|---|
| 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 | 10819-4077, 10819-4077-01, 10819-4077-02, 10819-4077-03, 10819-4077-04 |
| Expiration dates | 2022-02-20, 2022-03-20, 2022-04-20, 2022-06-20, 2022-07-20, 2022-08-20, 2022-09-20, 2022-10-20, 2022-11-20, 2022-12-20, 2023-01-20, 2023-02-20, 2023-03-20, 2023-04-20, 2023-05-20, 2023-06-20 |
Product
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; 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-0572-2022. 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.