FDA recall D-0764-2021

Professional Disposables International, Inc · Class II · drug

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

Reason for recall

SubPotent: Out of Specification

Distribution

Distributed Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2021-07-23
Report date: 2021-09-01
Termination date: 2023-05-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Woodcliff Lake, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0764-2021