NDC 49230-209
Delflex 5 ingredients solution
On the label: Fresenius Medical Care Renal Therapies Group, LLC.
Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Fresenius Medical Care Renal Therapies Group, LLC names for other drugs.
Recalls
- Jun 18, 2024 · Class II · Fresenius Medical Care Holdings, Inc.
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Lots: 24AU03024, exp. date 07/31/2025 - Dec 28, 2023 · Class II · Fresenius Medical Care Holdings, Inc.
Lack of Sterility Assurance
Lots: Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025 - Apr 28, 2021 · Class III · Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Lots: Lot #: a) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019, Exp. date August 2022 - Apr 28, 2021 · Class III · Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Lots: Lot #: 20SU02032, Exp. date July 2022 - Apr 28, 2021 · Class III · Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Lots: Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022 - Apr 28, 2021 · Class III · Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Lots: Lot #: 20PU04030, Exp. date June 2022 - Apr 28, 2021 · Class III · Fresenius Medical Care Holdings, Inc.
Temperature Abuse: Product exposed to temperature outside specified limits.
Lots: Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022 - Dec 20, 2017 · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Lots: Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and Dextro: every company that makes it
- Form
- solution, intraperitoneal
- Strength
- 5 ingredients
- Approval
- NDA NDA020171
- On the market since
- Aug 19, 1992
- Package NDCs
49230-209-3049230-209-3249230-209-5049230-209-5249230-209-62- Official label
- DailyMed (National Library of Medicine), updated Oct 30, 2026
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