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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65

D-0985-2017

June 26, 2017

Class II

Product summary

Firm
PharMedium Services, Llc
Event
Event 77634
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0985-2017

Official wording

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer

Code information: Lots: 171390026D Exp. 08/20/2017; 171370064D Exp. 8/16/2017; 171390027D Exp. 8/20/2017; 171420074D Exp. 8/21/2017; 171430062D Exp. 8/22/2017; 171440058D Exp. 8/23/2017; 171450001D Exp. 8/23/2017; 171450002D Exp. 8/23/2017; 171450056D Exp. 08/24/2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility