D-1023-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 8, 2018
- Initiation Date
- June 28, 2018
- Termination Date
- August 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 234,680 vials
Product Description
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Reason for Recall
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.