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Recall Observatory FDA recall evidence

Drug product

NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

D-0626-2020

December 16, 2019

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 84525
Status
Terminated
Classification
Class III
Quantity
864 bags
Official record key
drug-enforcement:D-0626-2020

Official wording

Reason: Subpotent Drug

Code information: Lot #s: 193040035S, Exp. 12/29/2019; 193120031S, Exp. 01/08/2020; 193150024S, Exp. 01/09/20; 193180030S, Exp. 01/12/20; 193240028S, Exp. 01/18/20; 193250022S, Exp. 01/19/20.

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent