Recalls / Class II
Class IID-0384-2021
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
- Brand name
- Sterile Water
- Generic name
- Water
- Active ingredient
- Water
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDC
- 0409-4887
- FDA application
- NDA018801
- Affected lot / code info
- Lot DN9185
Why it was recalled
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 49,525 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-05-03
- FDA classified
- 2021-05-14
- Posted by FDA
- 2021-05-26
- Terminated
- 2023-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0384-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.