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Recall Observatory FDA recall evidence

Drug product

Norepinephrine 8 mg per 250 mL (32 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 70324-577-01.

D-0932-2023

July 07, 2023

Class II

Product summary

Firm
SterRx, LLC
Event
Event 92657
Status
Terminated
Classification
Class II
Quantity
125,598 bags
Official record key
drug-enforcement:D-0932-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 490071, Exp 30-Jul-23; 490089, Exp 4-Aug-23; 490118, 490126, Exp 5-Aug-23; 490169, Exp 10-Aug-23; 491276, Exp 11-Aug-23; 491284, Exp 12-Aug-23; 491612, Exp 18-Aug-23; 497467, Exp 8-Dec-23; 497475, Exp 9-Dec-23; 499104, Exp 18-Jan-24; 499112, Exp 19-Jan-24; 499121, 499278, Exp 20-Jan-24; 499358, Exp 21-Jan-24; 502019, Exp 24-Mar-24; 502027, Exp 29-Mar-24; 502035, Exp 5-Apr-24; 503513, Exp 18-Apr-24; 504217, Exp 20-Apr-24

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility