Status
Terminated
Drug Enforcement D-813-2013
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Classification
Class II
Report Date
July 31, 2013
Termination Date
June 4, 2015
Product Information
- Product description
- Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
- Product quantity
- 268,700 vials
- Reason for recall
- Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Guam
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-813-2013
- Event ID
- 65731
- Recall initiation date
- June 27, 2013
- Center classification date
- July 22, 2013
- Code info
- Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
- More code info
- —