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Recall Observatory FDA recall evidence

Drug product

FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.

D-0172-2023

January 13, 2023

Class III

Product summary

Firm
OurPharma LLC
Event
Event 91520
Status
Terminated
Classification
Class III
Quantity
768 cassettes
Official record key
drug-enforcement:D-0172-2023

Official wording

Reason: Short Fill: Underfilled units.

Code information: Lots: 100122080003, Exp. 2/26/2023; 100122090001, Exp. 3/07/2023; 100122100002, Exp. 4/05/2023

Distribution pattern: IL and MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Short Fill: Underfilled units.