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Recall Observatory FDA recall evidence

Drug product

Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04

D-1168-2017

August 22, 2017

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 77956
Status
Terminated
Classification
Class II
Quantity
98,050 vials
Official record key
drug-enforcement:D-1168-2017

Official wording

Reason: Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Code information: Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18

Distribution pattern: United States Nationwide (including Puerto Rico) and Singapore

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility