Drug product
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
D-0384-2021
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 87831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49,525 vials
- Official record key
drug-enforcement:D-0384-2021
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Code information: Lot DN9185
Distribution pattern: Nationwide USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter