Why it was recalled
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Product description
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Lot numbers, UPCs & expiration codes
Lot #20SU03019, Exp 6/2022
Where it was sold
USA Nationwide
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-0389-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 14, 2021
- FDA report date
- May 26, 2021
- Quantity
- 709 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care, North America
Original FDA data
Every field from FDA enforcement report D-0389-2021, exactly as published.
Show all FDA fields
- City
- Ogden
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 87809
- Address
- 475 W 13th St
- Code information
- Lot #20SU03019, Exp 6/2022
- Postal code
- 84404-5554
- Report date
- May 26, 2021
- Product type
- Drugs
- Recall number
- D-0389-2021
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care, North America
- Product quantity
- 709 cases
- Termination date
- Apr 5, 2022
- Reason for recall
- Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 14, 2021
- Initial firm notification
- Letter
- Center classification date
- May 19, 2021