Why it was recalled
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Product description
Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
Lot numbers, UPCs & expiration codes
Lot #: 3A176011, Exp 10/18
Where it was sold
CA, IL.
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-1129-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 4, 2017
- FDA report date
- Sep 13, 2017
- Quantity
- 720 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Degasa Sa De Cv
Original FDA data
Every field from FDA enforcement report D-1129-2017, exactly as published.
Show all FDA fields
- City
- Jiutepec
- Status
- Terminated
- Country
- Mexico
- Event ID
- 78034
- Address
- Calle Centenario 15
- Address (line 2)
- Col. DEPORTIVA
- Code information
- Lot #: 3A176011, Exp 10/18
- Report date
- Sep 13, 2017
- Product type
- Drugs
- Recall number
- D-1129-2017
- Classification
- Class II
- Recalling firm
- Degasa Sa De Cv
- Product quantity
- 720 bottles
- Termination date
- Nov 24, 2020
- Reason for recall
- Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
- Distribution pattern
- CA, IL.
- Recall initiation date
- Aug 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2017