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.

Drug Recall

Official source record

Recall number: D-0864-2016
Event ID: 73118
Classification: Class I
Status: Terminated
Recalling company: Baxter Healthcare Corp.
Reason for recall: Presence of Particulate Matter: identified as dried skin.
Report date: June 1, 2016
Recall initiation date: January 21, 2016
Termination date: February 26, 2018
Distribution pattern: Nationwide and Puerto Rico

Drug product identifiers

Manufacturer: Baxter Healthcare Company
Brand name: CLINIMIX E
Generic name: LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE
Substance names: ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Product NDCs: 0338-0202; 0338-0206; 0338-0210; 0338-0214; 0338-1113; 0338-1115; 0338-1123; 0338-1125; 0338-1142; 0338-1144; 0338-1145; 0338-1147; 0338-1148; 0338-7020; 0338-7022; 0338-7024; 0338-7026; 0338-7028; 0338-7030; 0338-7032; 0338-7034; 0338-7036
Package NDCs: 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-1113-04; 0338-1115-04; 0338-1123-04; 0338-1125-04; 0338-1142-03; 0338-1144-03; 0338-1145-03; 0338-1147-03; 0338-1148-03; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04
Route: INTRAVENOUS

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Retrieved by Public Health Trace: July 28, 2026 ET

Frequently asked questions

What does a Class I mean?

FDA classifies this recall as Class I. See how to read an FDA recall record for what each classification level means.

Is this recall still active?

According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

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Official guidance and record verification

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How to interpret this historical record

This record is preserved as published by FDA, as of February 26, 2018.

Status as reported: Terminated.

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View the official FDA source

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