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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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 →Related recalls
Same brand · CLINIMIX E
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