Recalls / Class II
Class IID-0762-2021
Product
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.
- Affected lot / code info
- 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;
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
- 5,477 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-0762-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.