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Recall Observatory FDA recall evidence

Drug product

Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478

D-0632-2018

April 10, 2018

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 79799
Status
Terminated
Classification
Class III
Quantity
72 bags
Official record key
drug-enforcement:D-0632-2018

Official wording

Reason: cGMP deviations

Code information: Lot: 180660057S Exp. 6/5/2018

Distribution pattern: MA, WA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations