Baxter Recalls Premasol Sulfite-Free Amino Acid Injection Due to Discoloration
Baxter Healthcare is recalling 3,528 units of Premasol Sulfite-Free Amino Acid Injection due to yellow discoloration caused by a damaged overpouch.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a quality defect (discoloration due to oxidation) without reporting specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Baxter Healthcare Corporation is recalling 3,528 units of Premasol Sulfite-Free (Amino Acid) Injection, 10% concentration, 2000 mL bulk package. The affected product is identified by Lot # P333617 with an expiration date of 4/30/17. The product is a prescription-only intravenous solution distributed in the United States.
The recall was initiated due to customer reports of yellow discoloration in the solution. According to the source text, the yellow coloration is the result of the oxidation of the amino acid tryptophan, which occurred due to a damaged overpouch.
Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare Corporation for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE)
- Brand
- PREMASOL - SULFITE-FREE (AMINO ACID)
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Prescription Drug
- Affected units
- 3,528
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 #: P333617
- Exp 4/30/17
Distribution
Distribution scope not specified by the agency.
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