Why it was recalled
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Product description
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
Lot numbers, UPCs & expiration codes
Lot #:: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
Where it was sold
Distributed Nationwide in the USA and Isreal
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-0624-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 14, 2021
- FDA report date
- Jun 16, 2021
- Quantity
- 231,936 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medline Industries Inc
Original FDA data
Every field from FDA enforcement report D-0624-2021, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88005
- Address
- 3 Lakes Dr
- Code information
- Lot #:: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
- Postal code
- 60093-2753
- Report date
- Jun 16, 2021
- Product type
- Drugs
- Recall number
- D-0624-2021
- Classification
- Class III
- Recalling firm
- Medline Industries Inc
- Product quantity
- 231,936 packs
- Termination date
- Aug 7, 2024
- Reason for recall
- Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
- Distribution pattern
- Distributed Nationwide in the USA and Isreal
- Recall initiation date
- May 14, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2021