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Recall Observatory FDA recall evidence

Drug product

MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.

D-0318-2022

November 12, 2021

Class II

Product summary

Firm
SterRx, LLC
Event
Event 89059
Status
Terminated
Classification
Class II
Quantity
880 bags
Official record key
drug-enforcement:D-0318-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: S21292/BYI

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility