PDI Povidone-Iodine Prep Pad MEDIUM — Class II drug recall D-0758-2021
Terminated recall by Professional Disposables International, Inc, reported 2021-09-01, distributed nationwide. SubPotent: Out of Specification
| Recall number | D-0758-2021 |
|---|---|
| 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 | 53,588 cases |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00310819000147 |
| NDC | 10819-3883, 10819-3883-01, 10819-3883-03, 10819-3885, 10819-3885-01, 10819-3885-02 |
| Lot numbers | 11800977, 11800978, 11800979, 11801123, 11801124, 11801125, 11801126, 11801228, 11801230, 11801231, 11801232, 11801234, 11801417, 11801418, 11801419, 11801420, 11801421, 11801709, 11801710, 11900195, 11900196, 11900197, 11900370, 11900371, 11900372, 11900623, 11900624, 11900646, 11900647, 11900967, 11900968, 11900969, 11901043, 11901044, 11901318, 11901330, 11901331, 11901446, 11901447, 11901448 and 42 more |
Product
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,
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-0758-2021. 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.