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Heparin Sodium

TRACKED

Anti-coagulant

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 2 of 2 briefs for Heparin Sodium
REGULATORY INTELLIGENCE·Recall

FDA Class I Recall: SCA Pharmaceuticals' Heparin Sodium Contained Undeclared Benzyl Alcohol, Highlighting Critical Quality Control Gaps

SCA Pharmaceuticals initiated a Class I recall for 362 containers of Heparin Sodium 10,000 units/mL due to undeclared benzyl alcohol, mislabeled as parabens. This event, terminated in May 2021, underscores critical quality control and labeling deficiencies, posing significant risks for procurement and regulatory teams managing pharmaceutical supply chain integrity and patient safety.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2020-09-02 Recall
REGULATORY INTELLIGENCE·Recall

FDA Class II Recall: SCA Pharmaceuticals' Heparin Sodium Subpotency Exposes Critical Quality Control Failures

SCA Pharmaceuticals initiated a Class II recall of Heparin Sodium 5,000 units/mL due to subpotency, impacting hospitals in PA and CA. This event, coupled with a prior Class I recall for Heparin Sodium, signals persistent quality control deficiencies. Procurement and regulatory teams must scrutinize SCA's manufacturing processes and ensure robust supplier qualification to mitigate supply chain risks.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2020-06-24 Recall