D-0610-2021 Class III Terminated
FDA drug recall D-0610-2021 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: 285 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
- 285 cases
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
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022