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Recall Observatory FDA recall evidence

Drug product

FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.

D-0277-2024

December 28, 2023

Class I

Product summary

Firm
Denver Solutions, LLC DBA Leiters Health
Event
Event 93710
Status
Ongoing
Classification
Class I
Quantity
8,976 IV bags
Official record key
drug-enforcement:D-0277-2024

Official wording

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Code information: Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent