D-1023-2018 Class II Terminated
FDA drug recall D-1023-2018 was initiated by PFIZER on Jun 28, 2018 and is designated Class II. Reason for recall: Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination. The recall status is terminated (terminated Aug 25, 2022). Affected quantity: 234,680 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 8, 2018
- Initiation Date
- Jun 28, 2018
- Termination Date
- Aug 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1023-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026