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Recall Observatory FDA recall evidence

Drug product

Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-04

D-0049-2018

September 01, 2017

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 78063
Status
Terminated
Classification
Class II
Quantity
42 bags
Official record key
drug-enforcement:D-0049-2018

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