Drug product
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)
D-1167-2017
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 77956
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115,370 vials
- Official record key
drug-enforcement:D-1167-2017
Official wording
Reason: Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Code information: Lot: 760853A
Distribution pattern: United States Nationwide (including Puerto Rico) and Singapore
Derived failure modes
-
Sterility assurance
Lack of sterility