Pfizer Inc.: Drug Recall
Recall #D-0384-2021 · 05/03/2021
Class II: Risk
Recall Details
- Recall Number
- D-0384-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Pfizer Inc.
- Status
- Terminated
- Date Initiated
- 05/03/2021
- Location
- New York, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,525 vials
Reason for Recall
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Product Description
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
Distribution Pattern
Nationwide USA
Other Recalls by Pfizer Inc.
- Class II: Risk 08/04/2025
- Class II: Risk 08/04/2025
- Class II: Risk 07/10/2025
- Class II: Risk 07/10/2025
- Class II: Risk 05/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.