Why it was recalled
SubPotent: Out of Specification
Product description
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
Lot numbers, UPCs & expiration codes
SKU S23125 Lot #'s 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393
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-0764-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 11,039 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Professional Disposables International, Inc
Original FDA data
Every field from FDA enforcement report D-0764-2021, 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
- SKU S23125 Lot #'s 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393
- Postal code
- 07677-7604
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0764-2021
- Classification
- Class II
- Recalling firm
- Professional Disposables International, Inc
- Product quantity
- 11,039 cases
- Termination date
- May 31, 2023
- Reason for recall
- SubPotent: Out of Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Jul 23, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021