Status
Terminated
Drug Enforcement D-608-2013
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Classification
Class II
Report Date
June 26, 2013
Termination Date
May 15, 2015
Product Information
- Product description
- 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
- Product quantity
- 676,872 containers
- Reason for recall
- Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-608-2013
- Event ID
- 65400
- Recall initiation date
- June 6, 2013
- Center classification date
- June 20, 2013
- Code info
- Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
- More code info
- —