Baxter Recalls Travasol Amino Acid Injection Due to Sterility Concerns
Baxter Healthcare is recalling 14,622 bags of Travasol Amino Acid Injection because leaking containers prevent assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
Baxter Healthcare Corp. is recalling 14,622 bags of Travasol (Amino Acid) Injection, 10%, 2000 ml, Pharmacy Bulk Package. The product is identified by Lot P302646 with an expiration date of 5/31/15. The recall was initiated because the drug product was found leaking from the container, which means the sterility of the product cannot be assured.
The affected product is a prescription drug intended for intravenous use. It is distributed nationwide. The specific NDC for the recalled package is 0338-0644-06.
Healthcare providers and pharmacies should stop using the affected product and contact Baxter Healthcare for further instructions. Patients who have received this product should consult their healthcare provider.
The recalled product
- Product
- TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE)
- Brand
- TRAVASOL
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Amino Acid Injection
- Hazard
- Affected units
- 14,622
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: P302646
- Exp 5/31/15
Distribution
Distributed nationwide across the United States.
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