Recalls / Class III
Class IIID-0605-2021
Product
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
- Brand name
- Delflex
- Generic name
- Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
- Active ingredients
- Calcium Chloride, Dextrose Monohydrate, Magnesium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intraperitoneal
- NDCs
- 49230-206, 49230-209, 49230-212
- FDA application
- NDA020171
- Affected lot / code info
- 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
Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 950, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 672 cases
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-04-28
- FDA classified
- 2021-06-09
- Posted by FDA
- 2021-06-16
- Terminated
- 2021-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0605-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.