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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18

D-1072-2017

July 14, 2017

Class II

Product summary

Firm
Cantrell Drug Company
Event
Event 77780
Status
Terminated
Classification
Class II
Quantity
3039 bags
Official record key
drug-enforcement:D-1072-2017

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 10069, BUD: 7/24/2017; 10090, BUD: 7/26/2017; 10121, BUD: 7/31/2017; 10142, BUD: 8/3/2017; 10183, BUD: 8/8/2017; 10360, BUD: 8/31/2017; 10443, BUD: 9/14/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility