Drug product
0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
D-0969-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70303
- Status
- Terminated
- Classification
- Class I
- Quantity
- 661,128 containers
- Official record key
drug-enforcement:D-0969-2015
Official wording
Reason: Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Code information: Lot #: 44-002-JT (the lot number may be followed by 01 to 99), Exp 08/01/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter