Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atracurium Besylate Injection Recalled by Sagent Pharmaceuticals Inc Due to Lack of Assurance of Sterility: Recall initiated due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sagent Pharmaceuticals Inc directly.
Affected Products
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Quantity: 140,850 vials
Why Was This Recalled?
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sagent Pharmaceuticals Inc
Sagent Pharmaceuticals Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report