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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.

D-0307-2022

November 12, 2021

Class II

Product summary

Firm
SterRx, LLC
Event
Event 89059
Status
Terminated
Classification
Class II
Quantity
3540 bags
Official record key
drug-enforcement:D-0307-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: S21367/CBA 18-Nov-21 S21403/CCL 9-Dec-21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility