Recalls / Class II
Class IID-0764-2021
Product
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
- Affected lot / code info
- SKU S23125 Lot #'s 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393
Why it was recalled
SubPotent: Out of Specification
Recalling firm
- Firm
- 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
- 11,039 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-0764-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.