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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Baxter Healthcare Corp: Lack of Assurance of Sterility; increased complaints received for leaks

Agency Publication Date: March 31, 2015
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Affected Products

Product: Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04

Product code: 2B7722; Lot#: P306365, exp date: 8/31/2015

Lot Numbers:
2B7722
P306365
Product: 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

Product code: 2B1308; Lot#: P316497, exp date: 10/2015

Lot Numbers:
2B1308
P316497

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 70695
Status: Resolved
Manufacturer: Baxter Healthcare Corp
Manufactured In: United States
Units Affected: 2 products (7444 containers; 196,128 containers)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.