Drug product
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
D-0601-2025
Product summary
- Event
- Event 97385
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,639,996 pads
- Official record key
drug-enforcement:D-0601-2025
Official wording
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Code information: 61224050002
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent