PDI Povidone-Iodine Swabstick — Class II drug recall D-0761-2021
Terminated recall by Professional Disposables International, Inc, reported 2021-09-01, distributed nationwide. SubPotent: Out of Specification
| Recall number | D-0761-2021 |
|---|---|
| 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 | 51,926 cases |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00310819000185 |
| NDC | 10819-3883, 10819-3883-01, 10819-3883-03, 10819-3885, 10819-3885-01, 10819-3885-02 |
| Lot numbers | 11900761, 11900917, 11900918, 11901008, 11901009, 11901124, 11901125, 11901126, 11901127, 11901179, 11901180, 11901247, 11901248, 11901388, 11901389, 11901390, 11901419, 11901420, 11901480, 11901558, 11901590, 11901591, 11901592, 11901691, 11901692, 12000054, 12000055, 12000116, 12000117, 12000172, 12000173, 12000189, 12000190, 12000287, 12000288, 12000346, 12000347, 12000452, 12000453, 12000454 and 46 more |
| Expiration dates | 2022-11-03, 2022-11-04, 2022-11-05, 2022-11-06, 2022-11-07, 2022-11-08, 2022-11-09, 2022-11-10, 2022-11-11, 2022-11-12, 2022-11-13, 2022-11-14, 2022-11-15, 2022-11-16, 2022-11-17, 2022-11-18, 2022-11-19, 2022-11-20, 2022-11-21, 2022-11-22, 2022-11-23, 2022-11-24, 2022-11-25, 2022-11-26, 2022-11-27 and 61 more |
Product
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185
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-0761-2021. 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.