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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18

D-1070-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
8928 bags
Official record key
drug-enforcement:D-1070-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 10095, BUD: 7/27/2017; 10119, BUD: 7/31/2017; 10135, BUD: 8/2/2017; 10162, BUD: 8/6/2017; 10168, BUD: 8/7/2017; 10186, BUD: 8/9/2017; 10247, BUD: 8/15/2017; 10301, BUD: 8/21/2017; 10325, BUD: 8/24/2017; 10390, BUD: 9/5/2017; 10465, BUD: 9/18/2017; 10487, BUD: 9/20/2017; 10542, BUD: 9/27/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility