Recalls / Class II
Class IID-0265-2022
Product
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
- Brand name
- Dextrose
- Generic name
- Dextrose Monohydrate
- Active ingredient
- Dextrose Monohydrate
- Route
- Intravenous
- NDC
- 0409-7100
- FDA application
- NDA019466
- Affected lot / code info
- Lot: 4923608 Exp. 1MAY2022
Why it was recalled
Lack of sterility assurance: bag has the potential to leak.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 765 bags
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-11-30
- FDA classified
- 2021-12-02
- Posted by FDA
- 2021-12-08
- Terminated
- 2023-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0265-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.