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D-0301-2015 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-0301-2015 was initiated by Baxter Healthcare Corp. on Nov 25, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal The recall status is terminated (terminated Oct 28, 2015). Affected quantity: 7,220 bags.

Recall Details

Product Type: Drugs
Report Date: Dec 24, 2014
Initiation Date: Nov 25, 2014
Termination Date: Oct 28, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,220 bags

Product Description

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

Reason for Recall

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Distribution Pattern

Nationwide

Code Information

Product Code 2B7717 Lot # P311357, exp 12/31/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0301-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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