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Recall Observatory FDA recall evidence

Drug product

Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4

D-1585-2020

May 05, 2020

Class III

Product summary

Firm
Exela Pharma Sciences LLC
Event
Event 86288
Status
Terminated
Classification
Class III
Quantity
23,775 vials
Official record key
drug-enforcement:D-1585-2020

Official wording

Reason: Short Fill

Code information: Lot #P0000471, Catalog #2020TS002, Exp Date: 04/2021

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Short Fill