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Recall Observatory FDA recall evidence

Drug product

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

D-0078-2023

November 29, 2022

Class II

Product summary

Firm
OurPharma LLC
Event
Event 91229
Status
Terminated
Classification
Class II
Quantity
691 cassettes
Official record key
drug-enforcement:D-0078-2023

Official wording

Reason: Underfilled units.

Code information: Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.

Distribution pattern: MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Underfilled units.