PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick — Class II drug recall D-0764-2021
Terminated recall by Professional Disposables International, Inc, reported 2021-09-01, distributed nationwide. SubPotent: Out of Specification
| Recall number | D-0764-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Professional Disposables International, Inc, Woodcliff Lake, NJ, United States |
| Recall initiated | 2021-07-23 |
| Classified | 2021-08-20 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 11,039 cases |
| Reason classes | potency, specification failure |
| NDC | 10819-3890-01, 10819-3891-01 |
| Lot numbers | 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392, 12100393 |
Product
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
Reason for recall
SubPotent: Out of Specification
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-0764-2021. 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.