D-0864-2016 Class I Terminated
FDA drug recall D-0864-2016 was initiated by Baxter Healthcare Corp. on Jan 21, 2016 and is designated Class I. Reason for recall: Presence of Particulate Matter: identified as dried skin. The recall status is terminated (terminated Feb 26, 2018). Affected quantity: 7,436 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2016
- Initiation Date
- Jan 21, 2016
- Termination Date
- Feb 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,436 bags
Product Description
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Reason for Recall
Presence of Particulate Matter: identified as dried skin.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: P333930, Exp 05/31/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0864-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026