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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15

D-0443-2023

February 21, 2023

Class II

Product summary

Firm
Denver Solutions, LLC DBA Leiters Health
Event
Event 91762
Status
Terminated
Classification
Class II
Quantity
325,300 units
Official record key
drug-enforcement:D-0443-2023

Official wording

Reason: CGMP DEVIATIONS

Code information: Lot #: 2230895, Exp. Date 3/5/2023; 2230911, Exp. Date 3/11/2023; 2230913, Exp. Date 3/18/2023; 2230994, Exp. Date 3/27/2023; 2231006, Exp. Date 4/1/2023; 2231109, Exp. Date 4/19/2023; 2231126, Exp. Date 5/6/2023; 2231134, Exp. Date 5/10/2023; 2231140, Exp. Date 5/14/2023; 2231142, Exp. Date 5/20/2023; 2231156, Exp. Date 5/29/2023; 2231273, Exp. Date 6/3/2023; 2231285, Exp. Date 6/10/2023; 2231299, Exp. Date 6/17/2023; 2231331, Exp. Date 6/26/2023; 2330014, Exp. Date 7/9/2023; 2330025, Exp. Date 7/15/2023

Distribution pattern: Nationwide within the United States including VA or other Government facilities

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP DEVIATIONS