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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.

D-0125-2017

October 12, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 75567
Status
Terminated
Classification
Class II
Quantity
1550 units
Official record key
drug-enforcement:D-0125-2017

Official wording

Reason: Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.

Code information: Lot #: 162790012M, Exp. 1/3/2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility