Drug product
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04
D-0546-2018
Product summary
- Event
- Event 79267
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67,104 bottles
- Official record key
drug-enforcement:D-0546-2018
Official wording
Reason: Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Code information: Lot #: 16EJ0023, Exp 04/18
Distribution pattern: Nationwide in the USA and Curacao
Derived failure modes
-
Potency or specification failure
Subpotent