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Recall Observatory FDA recall evidence

Drug product

Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01

D-0037-2018

September 01, 2017

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 78063
Status
Terminated
Classification
Class II
Quantity
2232 bags
Official record key
drug-enforcement:D-0037-2018

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