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Recall Observatory FDA recall evidence

Drug product

ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09

D-1091-2020

March 16, 2020

Class II

Product summary

Firm
PharMEDium Services, LLC
Event
Event 85212
Status
Terminated
Classification
Class II
Quantity
900 units
Official record key
drug-enforcement:D-1091-2020

Official wording

Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Code information: 193520006D 3/18/2020 193530009D 3/19/2020

Distribution pattern: Distributed Nationwide in the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility