Why it was recalled
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 16EJ0023, Exp 04/18
Where it was sold
Nationwide in the USA and Curacao
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0546-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2018
- FDA report date
- Mar 7, 2018
- Quantity
- 67,104 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medline Industries Inc
Original FDA data
Every field from FDA enforcement report D-0546-2018, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79267
- Address
- Three Lakes Drive
- Code information
- Lot #: 16EJ0023, Exp 04/18
- Postal code
- 60093
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0546-2018
- Classification
- Class II
- Recalling firm
- Medline Industries Inc
- Product quantity
- 67,104 bottles
- Termination date
- Apr 29, 2020
- Reason for recall
- Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA and Curacao
- Recall initiation date
- Feb 15, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 26, 2018