D-0606-2021 Class III Terminated
FDA drug recall D-0606-2021 was initiated by Fresenius Medical Care Holdings, Inc. on April 28, 2021 and is designated Class III. Reason for recall: Temperature Abuse: Product exposed to temperature outside specified limits. The recall status is terminated (terminated September 17, 2021). Affected quantity: 49 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- June 16, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- September 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 cases
Product Description
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 21AK01022, Exp. date July 2022; 20SK01022, Exp. date June 2022