Drug product
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
D-0136-2020
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 83947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17832 bags
- Official record key
drug-enforcement:D-0136-2020
Official wording
Reason: Lack of Assurance of Sterility: Bag has the potential to leak.
Code information: Lot #: 87-095-JT Exp. 1MAR2020
Distribution pattern: Nationwide in the United States and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility