The Recall Desk
CriticalFDA (Drugs)·D-0864-2016·Announced 2016-06-01

Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter

Baxter Healthcare is recalling 7,436 bags of Clinimix E injection due to the presence of dried skin particulate matter. The product was distributed nationwide and in Puerto Rico.

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 source metadata explicitly identifies the agency classification as 'Class I', which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 7,436 bags of CLINIMIX E 5/15 sulfite-free Injection, 1000 mL, due to the presence of particulate matter identified as dried skin. The affected product is a prescription-only intravenous solution containing amino acids, electrolytes, and dextrose, manufactured by Baxter Healthcare Corporation in Deerfield, IL.

The specific lot involved is P333930, with an expiration date of 05/31/2017. The product was distributed nationwide and in Puerto Rico. The recall is classified as FDA Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

Healthcare providers and consumers should stop using the affected product immediately. Patients who have received this product should contact their healthcare provider for guidance. Baxter Healthcare is the firm responsible for the recall.

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
Affected units
7,436

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 #: P333930
  • Exp 05/31/2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same brand · CLINIMIX E