D-1167-2017 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
- 115,370 vials
Product Description
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
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: 760853A