Why it was recalled
SubPotent: Out of Specification
Product description
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.
Lot numbers, UPCs & expiration codes
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;
Where it was sold
Distributed Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0760-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 41,105 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Professional Disposables International, Inc
Original FDA data
Every field from FDA enforcement report D-0760-2021, exactly as published.
Show all FDA fields
- City
- Woodcliff Lake
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88326
- Address
- 400 Chestnut Ridge Rd
- Code information
- 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;
- Postal code
- 07677-7604
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0760-2021
- Classification
- Class II
- Recalling firm
- Professional Disposables International, Inc
- Product quantity
- 41,105 cases
- Termination date
- May 31, 2023
- Reason for recall
- SubPotent: Out of Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Jul 23, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021