Status
Terminated
Drug Enforcement D-619-2013
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Classification
Class II
Report Date
July 3, 2013
Termination Date
July 17, 2015
Product Information
- Product description
- 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
- Product quantity
- 2,933,936 units
- Reason for recall
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
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-619-2013
- Event ID
- 61918
- Recall initiation date
- May 4, 2012
- Center classification date
- June 21, 2013
- Code info
- Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12
- More code info
- —