Recalls / Class II
Class IID-0759-2021
Product
PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154
- Brand name
- Pvp Iodine Prep Pad
- Generic name
- Providone Iodine
- Active ingredient
- Povidone-iodine
- Route
- Topical
- NDCs
- 10819-3883, 10819-3885
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot #'s 11801215, EXP 2021-08-22; 11801504, EXP 2021-11-06; 11801717,EXP 2021-12-07; 11900421, EXP 2022-04-04; 11901076, EXP 2022-08-29; 11901571, EXP 2022-11-19; 12000388, EXP 2023-03-13; 12001533 EXP 2023-07-28; 12100459 EXP 2024-03-31;
Why it was recalled
SubPotent: Out of Specification
Recalling firm
- Firm
- Professional Disposables International, Inc
- Manufacturer
- Professional Disposables International, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Chestnut Ridge Rd, N/A, Woodcliff Lake, New Jersey 07677-7604
Distribution
- Quantity
- 1982 cases
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2021-07-23
- FDA classified
- 2021-08-20
- Posted by FDA
- 2021-09-01
- Terminated
- 2023-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0759-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.