November 2014 FDA Recall Clinimix E by Baxter Healthcare Corp.
D-0301-2015 - Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on November 25, 2014 for the product Clinimix E. The FDA reported the reason for recall as lack of assurance of sterility; leaks were observed from the bag seam and port seal. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0301-2015
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
11-25-2014
12-24-2014
7,220 bags
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.
Baxter Healthcare Corp.
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.
Nationwide
10-28-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Batch or Lot Expiration Information
Lot# Product Code 2B7717
Lot# P311357, exp 12/31/2015
