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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.

D-0280-2024

December 28, 2023

Class I

Product summary

Firm
Denver Solutions, LLC DBA Leiters Health
Event
Event 93710
Status
Ongoing
Classification
Class I
Quantity
12,564 IV bags
Official record key
drug-enforcement:D-0280-2024

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 #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent