Status
Terminated
Drug Enforcement D-686-2013
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Classification
Class II
Report Date
July 17, 2013
Termination Date
October 28, 2014
Product Information
- Product description
- Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
- Product quantity
- 168,300 vals
- Reason for recall
- Presence of Particulate Matter: visible particles were identified floating in the primary container.
- 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-686-2013
- Event ID
- 65226
- Recall initiation date
- May 2, 2013
- Center classification date
- July 8, 2013
- Code info
- Lot 07-067-DK Exp. 07/13
- More code info
- —