Recalls / Class III
Class IIID-0610-2021
Product
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
- 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) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, 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
- 285 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-0610-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.