D-1168-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 27, 2017
- Initiation Date
- August 22, 2017
- Termination Date
- February 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,050 vials
Product Description
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.
Distribution Pattern
United States Nationwide (including Puerto Rico) and Singapore
Code Information
Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18