Drug product
0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
D-836-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64792
- Status
- Terminated
- Classification
- Class I
- Quantity
- 691,356 containers
- Official record key
drug-enforcement:D-836-2013
Official wording
Reason: Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Code information: Lot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter