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Recall Observatory FDA recall evidence

Drug product

Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01

D-0043-2018

September 01, 2017

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 78063
Status
Terminated
Classification
Class II
Quantity
4452 bags
Official record key
drug-enforcement:D-0043-2018

Official wording

Reason: Subpotent Drug

Code information: All unexpired lots.

Distribution pattern: Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent