CLASS II Drug recall · Reported 1 Sep 2021 · FDA Enforcement Report
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's) recalled
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional, 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-0763-2021
- FDA event ID
- 88326
- Recalling firm
- Professional Disposables International, Woodcliff Lake, NJ
- 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-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
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 11901080, EXP 2023-04-14; 11901339, EXP 2023-04-15; 11901755, EXP 2023-04-16; 12000016, EXP 2023-04-17; 12000397, EXP 2023-04-18; 12000987, EXP 2023-04-19; 12001578, EXP 2023-04-20; 12001814, EXP 2023-04-21;
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-Iodine Prep Pad Medium, 1 Prep Pad [] recalledPvp Iodine Prep Pad | 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-Iodine Prep Pad Medium, 1 Prep Pad [] recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |