Drug product
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
D-263-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 63432
- Status
- Terminated
- Classification
- Class I
- Quantity
- 136,224 flexible containers
- Official record key
drug-enforcement:D-263-2013
Official wording
Reason: Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Code information: Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulates