Why it was recalled
SubPotent: Out of Specification
Product description
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
Lot numbers, UPCs & expiration codes
Lot #'s 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13;
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-0762-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 5,477 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Professional Disposables International, Inc
Original FDA data
Every field from FDA enforcement report D-0762-2021, 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 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13;
- Postal code
- 07677-7604
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0762-2021
- Classification
- Class II
- Recalling firm
- Professional Disposables International, Inc
- Product quantity
- 5,477 cases
- Termination date
- May 31, 2023
- Reason for recall
- SubPotent: Out of Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Jul 23, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021