April 2021 FDA Recall Delflex by Fresenius Medical Care, North America
D-0389-2021 - Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
This Class II drug recall was voluntarily initiated by Fresenius Medical Care, North America on April 14, 2021 for the product Delflex. The FDA reported the reason for recall as labeling; label mix-up; 4.25% dextrose bag was found inside a 1.5% dextrose box.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0389-2021
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
04-14-2021
05-26-2021
709 cases
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Medical Care, North America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
04-05-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Batch or Lot Expiration Information
Lot# 20SU03019, Exp 6/2022
