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Recall Observatory FDA recall evidence

Drug product

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.

D-0931-2023

July 07, 2023

Class II

Product summary

Firm
SterRx, LLC
Event
Event 92657
Status
Terminated
Classification
Class II
Quantity
132,299 bags
Official record key
drug-enforcement:D-0931-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 490062, Exp 22-Jul-23; 490151, Exp 28-Jul-23; 490732, Exp 6-Aug-23; 491591, Exp 17-Aug-23; 491604, Exp 18-Aug-23; 494418, Exp 16-Nov-23; 494426, Exp 17-Nov-23; 494434, Exp 23-Nov-23; 496755, Exp 25-Nov-23; 497424, Exp 3-Dec-23; 497432, Exp 4-Dec-23; 497441, 497459, Exp 7-Dec-23; 498005, Exp 10-Dec-23; 499075, Exp 22-Jan-24; 499083, 499091, Exp 25-Jan-24; 499391, Exp 26-Jan-24; 501964, Exp 23-Mar-24; 501972, Exp 28-Mar-24; 501981, Exp 30-Mar-24; 501999, Exp 6-Apr-24; 502001, Exp 7-Apr-24

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility