Why it was recalled
SubPotent: Out of Specification
Product description
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
Lot numbers, UPCs & expiration codes
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;
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-0759-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 1982 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Professional Disposables International, Inc
Original FDA data
Every field from FDA enforcement report D-0759-2021, 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 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;
- Postal code
- 07677-7604
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0759-2021
- Classification
- Class II
- Recalling firm
- Professional Disposables International, Inc
- Product quantity
- 1982 cases
- Termination date
- May 31, 2023
- Reason for recall
- SubPotent: Out of Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Jul 23, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021