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
D-0764-2021
Product summary
- Event
- Event 88326
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,039 cases
- Official record key
drug-enforcement:D-0764-2021
Official wording
Reason: SubPotent: Out of Specification
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
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
SubPotent