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CHEMICAL & LIFE SCIENCES INTELLIGENCE
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Sodium Chloride

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Osmotic Laxative

CAS7647-14-5HSN29339900
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
18
Manufacturers monitored
3
Intelligence briefs
0
Active regulatory actions
1
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INTELLIGENCE

Showing 3 of 3 briefs for Sodium Chloride
REGULATORY INTELLIGENCE·Product Recall

B. Braun Medical Inc. Initiates Class II Recall of 0.9% Sodium Chloride Injection Over Sterility Concerns

B. Braun Medical Inc. has initiated a voluntary Class II recall of 23,100 containers of 0.9% Sodium Chloride Injection USP due to a lack of sterility assurance stemming from potential fluid leakage at weld sites. This event, originating from their Allentown, PA facility, necessitates immediate action for procurement and supply chain leaders to assess exposure and secure alternative supplies of this critical injectable.

90-Day Activity
PSPriya Subramaniam· Intelligence Analyst
2025-08-20
REGULATORY INTELLIGENCE·Warning Letter

Fresenius Medical Care Recalls 3.6 Million Sodium Chloride Injections Over Sterility Concerns

Fresenius Medical Care Holdings, Inc. has initiated a nationwide Class II recall (D-0490-2025) for 3,651,468 containers of 0.9% Sodium Chloride Injection, USP, due to a lack of sterility assurance. This event, originating from their Waltham, MA operations, necessitates immediate review of supply chain resilience for critical intravenous solutions. Procurement and regulatory teams must assess exposure and contingency plans to mitigate potential disruptions and ensure patient safety.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2025-07-02
REGULATORY INTELLIGENCE·Recall

B. Braun Medical Inc. Initiates Class II Recall of Sodium Chloride Irrigation Due to Particulate Matter

B. Braun Medical Inc. has initiated a voluntary Class II recall of 32,256 bottles of 0.9% Sodium Chloride Irrigation USP due to particulate matter. This event, identified as D-0353-2025, impacts nationwide distribution, necessitating immediate action from procurement and supply chain leaders to quarantine affected lots and secure alternative sourcing for this critical medical product.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2025-04-16