Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Product description
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Lot numbers, UPCs & expiration codes
Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
Where it was sold
Nationwide within 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-0610-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 28, 2021
- FDA report date
- Jun 16, 2021
- Quantity
- 285 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0610-2021, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 87907
- Address
- 920 Winter St Bld 950
- Code information
- Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
- Postal code
- 02451-1521
- Report date
- Jun 16, 2021
- Product type
- Drugs
- Recall number
- D-0610-2021
- Classification
- Class III
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 285 cases
- Termination date
- Sep 17, 2021
- Reason for recall
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 28, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2021