Recalls / Class II
Class IID-0546-2018
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
- Brand name
- Povidone-iodine
- Generic name
- Povidone-iodine
- Active ingredient
- Povidone-iodine
- Route
- Topical
- NDC
- 53329-938
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot #: 16EJ0023, Exp 04/18
Why it was recalled
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Recalling firm
- Firm
- Medline Industries Inc
- Manufacturer
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Three Lakes Drive, N/A, Northfield, Illinois 60093
Distribution
- Quantity
- 67,104 bottles
- Distribution pattern
- Nationwide in the USA and Curacao
Timeline
- Recall initiated
- 2018-02-15
- FDA classified
- 2018-02-26
- Posted by FDA
- 2018-03-07
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0546-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.