Recalls / Class II
Class IID-0760-2021
Product
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.
- 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 11900790, EXP 2021-07-25; 11900919, EXP 2021-07-28; 11900920, EXP 2021-08-12; 11900921, EXP 2021-08-15; 11901106, EXP 2021-08-27; 11901107, EXP 2021-08-30; 11901128, EXP 2021-09-05; 11901129, EXP 2021-09-12;11901249, EXP 2021-09-25; 11901250, EXP 2021-10-17; 11901391, EXP 2021-10-19; 11901392, EXP 2021-10-22; 11901438, EXP 2021-10-24; 11901439, EXP 2021-10-08; 11901457, EXP 2021-11-07; 11901541, EXP 2021-11-18; 11901603, EXP 2021-11-19; 11901604, EXP 2021-12-19; 11901669, EXP 2021-12-19; 11901670, EXP 2021-11-16; 11901702, EXP 2021-12-02; 11901703, EXP 2021-12-14; 12000082, EXP 2021-12-19; 12000083, EXP 2022-01-24; 12000118, EXP 2022-01-03; 12000119, EXP 2022-01-30; 12000249, EXP 2022-01-10; 12000250, EXP 2022-01-10; 12000348, EXP 2022-02-13; 12000349, EXP 2022-02-28; 12000398, EXP 2022-02-05; 12000456, EXP 2022-03-12; 12000457, EXP 2022-03-12; 12000683, EXP 2022-03-23; 12000684, EXP 2022-03-30; 12000685, EXP 2022-04-04; 12000922, EXP 2022-05-15; 12000923, EXP 2022-05-19; 12000927, EXP 2022-05-21; 12000989, EXP 2022-06-15; 12000990, EXP 2022-06-05; 12000991, EXP 2022-06-10; 12001154, EXP 2022-06-26; 12001155, EXP 2022-06-24; 12001231, EXP 2022-07-26; 12001232, EXP 2022-07-21; 12001243, EXP 2022-07-03; 12001244, EXP 2022-07-04; 12001537, EXP 2022-08-31; 12001538, EXP 2022-08-31; 12001539, EXP 2022-08-31; 12001540, EXP 2022-09-30; 12001666, EXP 2022-09-30; 12001667, EXP 2022-09-30; 12001668, EXP 2022-09-30; 12001669, EXP 2022-09-30; 12001841, EXP 2022-10-31; 12001842, EXP 2022-10-31; 12001959, EXP 2022-10-31; 12002072, EXP 2022-11-30; 12100123, EXP 2023-02-28; 12100124, EXP 2023-02-28; 12100454, EXP 2023-03-31; 12100455, EXP 2023-03-31; 12100590, EXP 2023-04-30; 12100591, EXP 2023-04-30;
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
- 41,105 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-0760-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.