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Recall Observatory FDA recall evidence

Drug product

morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78

D-0131-2018

September 26, 2017

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 78694
Status
Terminated
Classification
Class III
Quantity
Unknown
Official record key
drug-enforcement:D-0131-2018

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date

Code information: Lot:172410028C; Exp. 11/28/2017 Lot: 172470030C; Exp. 12/04/2017

Distribution pattern: Nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing