Why it was recalled
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Product description
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
Lot numbers, UPCs & expiration codes
Part # P-1001; Lots: 58471; 59003; 59723; 60373; 60807; 61187; 61523; 61998; 63974; 64701; 65864 Part # P-1001-8S Lots: 58368; 58371; 58472; 58499; 58686; 58687; 58688; 58816; 58817; 58818; 59002; 59004; 59333; 59334; 59335; 59574; 59724; 59725; 60157; 60237; 60374; 60375; 60507; 60586; 61101; 61368; 61427; 61618; 61750; 61751; 61999; 62067; 62224; 62226; 62557; 62558; 62954; 62955; 63441; 63442; 63443; 63507; 63508; 64002; 64129; 64243; 64245; 64592; 64840; 65081; 65327; 65583; 65681; 65882; 66026; 66040; 66110; 66193; Part # P-1011 Lots: 66549; 66916 Part # P-1011-8S Lots: 66404; 66580; 66622; 66709; 66856
Where it was sold
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
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-0252-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2017
- FDA report date
- Feb 7, 2018
- Quantity
- 11,750 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medline Industries Inc
Original FDA data
Every field from FDA enforcement report D-0252-2018, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78575
- Address
- Three Lakes Drive
- Code information
- Part # P-1001; Lots: 58471; 59003; 59723; 60373; 60807; 61187; 61523; 61998; 63974; 64701; 65864 Part # P-1001-8S Lots: 58368; 58371; 58472; 58499; 58686; 58687; 58688; 58816; 58817; 58818; 59002; 59004; 59333; 59334; 59335; 59574; 59724; 59725; 60157; 60237; 60374; 60375; 60507; 60586; 61101; 61368; 61427; 61618; 61750; 61751; 61999; 62067; 62224; 62226; 62557; 62558; 62954; 62955; 63441; 63442; 63443; 63507; 63508; 64002; 64129; 64243; 64245; 64592; 64840; 65081; 65327; 65583; 65681; 65882; 66026; 66040; 66110; 66193; Part # P-1011 Lots: 66549; 66916 Part # P-1011-8S Lots: 66404; 66580; 66622; 66709; 66856
- Postal code
- 60093
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0252-2018
- Classification
- Class II
- Recalling firm
- Medline Industries Inc
- Product quantity
- 11,750 cases
- Termination date
- Aug 28, 2023
- Reason for recall
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
- Distribution pattern
- Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
- Recall initiation date
- Sep 21, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2018