Critical FDA (Drugs)·D-1158-2014·Announced 2014-03-26

Baxter Recalls Clinimix E Bags Due to Particulate Matter

Baxter Healthcare is recalling 14,574 bags of Clinimix E IV solution found to contain particulate matter, including wood, sodium citrate, and dextrose.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are scored as 5 (Critical).

Plain-English summary

Baxter Healthcare Corporation is recalling 14,574 bags of Clinimix E (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) Injection. The product is a prescription-only, sulfite-free 4.25% Amino Acid in 25% Dextrose solution in 1000 mL Clarity Dual Chamber Container bags. The specific lot affected is P287045, with an expiration date of 6/2014 and NDC 0338-1115-04.

The recall was initiated due to the presence of particulate matter in the solution. The identified particulates include wood, sodium citrate, and dextrose. The product was distributed nationwide in the United States.

Healthcare providers and patients should stop using the affected product immediately. Baxter Healthcare is the recalling firm. Consumers and healthcare facilities should contact Baxter Healthcare for further instructions on how to return or dispose of the recalled product.

The recalled product

Product: CLINIMIX E (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)
Brand: CLINIMIX E
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: particulate-matter
contamination
Affected units: 14,574

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot#: P287045
Exp 6/2014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same brand · CLINIMIX E

Critical
Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter
FDA (Drugs) · 2016-06-01
Severe
Baxter Recalls Clinimix E Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-04-08
High
Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns
FDA (Drugs) · 2014-12-24
Severe
Baxter Recalls Clinimix E IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26

Same manufacturer · Baxter Healthcare Corp.

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