FDA-Drug2015-03-11Class II
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
Sagent Pharmaceuticals Inc
Hazard
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.
Sold states
Nationwide and Puerto Rico
Affected count
140,850 vials
Manufactured in
1901 N Roselle Rd Ste 700, N/A, Schaumburg, IL, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2015Don't want to check this manually?
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