CLASS II Drug recall · Reported 1 Sep 2021 · FDA Enforcement Report
PDI Povidone-Iodine Prep Pad Medium, 1 Prep Pad [] recalled
Professional Disposables International is recalling PDI Povidone-Iodine Prep Pad Medium, 1 Prep Pad [], Professional Disposables, distributed nationwide in the US. The recall was initiated on 23 Jul 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0758-2021
- FDA event ID
- 88326
- Recalling firm
- Professional Disposables International, Woodcliff Lake, NJ
- Brand
- Pvp Iodine Prep Pad
- Manufacturer
- Professional Disposables International, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2021
- FDA classified
- 20 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Jul 2021 | Recall initiated by company | |
| 20 Aug 2021 | Classified by FDA | +28 days |
| 1 Sep 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SubPotent: Out of Specification
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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,
Where it was distributed
Distributed Nationwide in the US
Questions about this recall
Why was it recalled?
SubPotent: Out of Specification
Which lots are affected?
Lot #'s EXP date 11800977, 2021-07-31; 11800978 2021-08-02; 11800979 2021-08-04; 11801123 2021-08-06; 11801124 2021-08-09; 11801125 2021-08-15; 11801126 2021-08-16; 11801228 2021-08-28; 11801230 2021-09-11; 11801231 2021-09-13; 11801232 2021-09-18; 11801234 2021-10-25; 11801417 2021-10-28; 11801418 2021-11-01; 11801419 2021-11-07; 11801420 2021-11-15; 11801421 2021-11-20; 11801709 2021-11-29; 11801710 2021-12-04; 11900195 2022-02-19; 11900196 2022-02-21; 11900197 2022-02-25; 11900370 2022-04-01; 11900372 2022-04-03; 11900371 2022-04-05; 11900647 2022-05-04; 11900623 2022-05-21; 11900624 2022-05-24; 11900646 2022-05-29; 11900967 2022-08-13; 11900968 2022-08-26; 11900969 2022-08-28; 11901043 2022-09-11; 11901044 2022-09-18; 11901318 2022-10-03; 11901330 2022-10-08; 11901331 2022-10-16; 11901446 2022-10-28; 11901447 2022-11-19; 11901448 2022-12-19; 11901739 2023-01-02; 11901752 2023-01-09; 12000045 2023-01-14; 12000048 2023-01-18; 12000046 2023-01-21; 12000047 2023-01-24; 12000333 2023-01-25; 12000675 2023-02-16; 12000334 2023-02-27; 12000335 2023-02-27; 12000336 2023-02-28; 12000676 2023-03-16; 12000815 2023-03-29; 12000816 2023-05-05; 12000914 2023-05-13; 12000915 2023-05-18; 12000951 2023-05-22; 12000950 2023-06-01; 12001366 2023-08-12; 12001367 2023-08-14; 12001368 2023-08-17; 12001370 2023-08-21; 12001369 2023-08-21; 12001371 2023-08-25; 12001372 2023-09-30; 12001818 2023-09-30; 12001820 2023-09-30; 12001819 2023-11-30; 12001821 2023-11-30; 12001822 2023-11-30; 12001972 2023-12-31; 12001973 2023-12-31; 12001974 2023-12-31; 12001975 2023-12-31; 12001976 2023-12-31; 12001977 2023-12-31; 12001978 2023-12-31; 12100080 2023-12-31; 12100081 2023-12-31; 12100082 2024-02-29; 12100084 2024-02-29; 12100447 2024-03-31; 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, 11901739, 11901752, 12000045, 12000046, 12000047, 12000048, 12000333, 12000334, 12000335, 12000336, 12000675, 12000676, 12000815, 12000816, 12000914, 12000915, 12000950, 12000951, 12001366, 12001367, 12001368, 12001369, 12001370, 12001371, 12001372, 12001818, 12001819, 12001820, 12001821, 12001822, 12001972, 12001973, 12001974, 12001975, 12001976, 12001977, 12001978, 12100080, 12100081, 12100082, 12100084 and 12100447
Where was it sold?
Distributed Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 88326This product is part of a recall event; the main page for the event is PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick recalled | Professional Disposables International | Potency & Assay | Nationwide | |
| CLASS II | PDI Povidone-Iodine Cleansing Scrub Swabstick (1's) recalled | Professional Disposables International | Potency & Assay | Nationwide | |
| CLASS II | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide | |
| CLASS II | PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide | |
| CLASS II | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's) recalled | Professional Disposables International | Potency & Assay | Nationwide | |
| CLASS II | PDI Povidine Iodine Swabstick (1's), 1 swabstick recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |
More recalls from Professional Disposables International
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Swabstick | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Maxi Swabstick | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Swab | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PDI Povidine Iodine Swabstick (1's), 1 swabstick recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |
| Drug | CLASS II | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's) recalled | Professional Disposables International | Potency & Assay | Nationwide |
Other Providone Iodine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PDI Povidine Iodine Swabstick (1's), 1 swabstick recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |
| Drug | CLASS II | PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |
| Drug | CLASS II | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |