Baxter Recalls ProSol Amino Acid Injection Due to Particulate Matter
Baxter Healthcare is recalling 6,204 bags of ProSol Amino Acid Injection because a retention sample contained particulate matter. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves an intravenous drug with particulate matter, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 6,204 bags of ProSol (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bags. The product is identified by Lot # P306225 and has an expiration date of 08/14. The recall was initiated due to the identification of particulates in a retention sample.
The particulates were identified as a mixture of the amino acid leucine and inorganic material containing iron, silicone, and chlorine. The product is a prescription-only intravenous solution manufactured by Baxter Healthcare Corporation, Clinitec Nutrition Division, in Deerfield, IL.
The affected product was distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- PROSOL (VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE)
- Brand
- PROSOL
- Manufacturer
- Baxter Healthcare Corp
- Category
- Drug — Amino Acid Injection
- Affected units
- 6,204
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 #: P306225
- Exp 08/14
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Baxter Healthcare Corp
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateBaxter Recalls Premasol Sulfite-Free Amino Acid Injection Due to Discoloration
FDA (Drugs) · 2017-01-18
- SevereBaxter Recalls Travasol Amino Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2013-12-25
- CriticalBaxter Recalls Clinimix IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- CriticalBaxter Recalls Clinimix E Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- SevereBaxter Recalls Clinimix E IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26