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Recall Observatory FDA recall evidence

Drug product

Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01

D-0036-2018

September 01, 2017

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 78063
Status
Terminated
Classification
Class II
Quantity
1308 bags
Official record key
drug-enforcement:D-0036-2018

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