Drug recall D-1168-2017

Class II Terminated reported Sep 27, 2017

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Pfizer Inc., New York, NY
Quantity
98,050 vials
Distribution
United States Nationwide (including Puerto Rico) and Singapore
Type
Voluntary: Firm initiated
Recall initiated
August 22, 2017
Terminated
February 19, 2023

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