Why it was recalled
Lack of Assurance of Sterility and cGMP Deviations
Product description
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Lot numbers, UPCs & expiration codes
Lot # SD2070420925 Exp. Date 09/2019, and Lot # SD2070421201 and Lot # SD2070420601, Exp. Date 12/2019
Where it was sold
Product was distributed throughout the United States
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-0134-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2017
- FDA report date
- Jan 3, 2018
- Quantity
- 150,250 alcohol pads
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Simple Diagnostics, Inc.
Original FDA data
Every field from FDA enforcement report D-0134-2018, exactly as published.
Show all FDA fields
- City
- Coral Springs
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78657
- Address
- 11555 Heron Bay Blvd Ste 200
- Code information
- Lot # SD2070420925 Exp. Date 09/2019, and Lot # SD2070421201 and Lot # SD2070420601, Exp. Date 12/2019
- Postal code
- 33076-3362
- Report date
- Jan 3, 2018
- Product type
- Drugs
- Recall number
- D-0134-2018
- Classification
- Class II
- Recalling firm
- Simple Diagnostics, Inc.
- Product quantity
- 150,250 alcohol pads
- Termination date
- Sep 19, 2018
- Reason for recall
- Lack of Assurance of Sterility and cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Sep 5, 2017
- Initial firm notification
- Press Release
- Center classification date
- Dec 26, 2017