Drug 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
D-0265-2022
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 89100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 765 bags
- Official record key
drug-enforcement:D-0265-2022
Official wording
Reason: Lack of sterility assurance: bag has the potential to leak.
Code information: Lot: 4923608 Exp. 1MAY2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of sterility