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Recall Observatory FDA recall evidence

Drug product

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.

D-0933-2023

July 07, 2023

Class II

Product summary

Firm
SterRx, LLC
Event
Event 92657
Status
Terminated
Classification
Class II
Quantity
92,148 bags
Official record key
drug-enforcement:D-0933-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 490097, Exp 3-Aug-23; 490142, Exp 10-Aug-23; 491292, Exp 13-Aug-23; 494442, Exp 26-Nov-23; 496763, Exp 30-Nov-23; 496771, Exp 1-Dec-23; 497408, Exp 2-Dec-23; 497416, Exp 3-Dec-23; 499438, Exp 28-Jan-24; 501032, Exp 8-Feb-24; 501059, Exp 15-Feb-24; 502043, Exp 28-Mar-24; 502051, Exp 31-Mar-24; 503505, Exp 4-Apr-24; 504031, Exp 7-Apr-24; 504250, Exp 19-Apr-24

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility