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Recall Observatory FDA recall evidence

Drug product

Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05

D-0398-2015

February 23, 2015

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 70600
Status
Terminated
Classification
Class II
Quantity
140,720 vials
Official record key
drug-enforcement:D-0398-2015

Official wording

Reason: 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.

Code information: Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility