Recalls / Class II
Class IID-0763-2021
Product
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
- Affected lot / code info
- Lot #'s 11901080, EXP 2023-04-14; 11901339, EXP 2023-04-15; 11901755, EXP 2023-04-16; 12000016, EXP 2023-04-17; 12000397, EXP 2023-04-18; 12000987, EXP 2023-04-19; 12001578, EXP 2023-04-20; 12001814, EXP 2023-04-21;
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
- 3,113 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-0763-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.