0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Reported: December 3, 2014 Initiated: October 14, 2014 #D-0285-2015
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 16,487,040 bags
- Distribution
- Nationwide, Puerto Rico, and U.S. Virgin Islands.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.. Recalled by Hospira Inc.. Units affected: 16,487,040 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 3, 2014. Severity: Moderate. Recall number: D-0285-2015.
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