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Recall Observatory FDA recall evidence

Drug product

S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9

D-0176-2023

January 13, 2023

Class II

Product summary

Firm
Nephron Sc Inc
Event
Event 91451
Status
Terminated
Classification
Class II
Quantity
925,920 vials
Official record key
drug-enforcement:D-0176-2023

Official wording

Reason: Short Fill

Code information: Lot #: 126461, 126431 Exp. 04/30/2023

Distribution pattern: Nationwide within the United States including Puerto Rico. Guatamala

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Short Fill