Status
Terminated
Drug Enforcement D-243-2013
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Classification
Class II
Report Date
April 10, 2013
Termination Date
April 6, 2015
Product Information
- Product description
- 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
- Product quantity
- 624,240 units
- Reason for recall
- Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-243-2013
- Event ID
- 64481
- Recall initiation date
- February 18, 2013
- Center classification date
- April 4, 2013
- Code info
- Lot #: 22-028-JT Exp 04/14
- More code info
- —