Status
Terminated
Drug Enforcement D-308-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Classification
Class II
Report Date
May 8, 2013
Termination Date
September 18, 2014
Product Information
- Product description
- Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
- Product quantity
- 26,100 vials
- Reason for recall
- Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
- 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-308-2013
- Event ID
- 64720
- Recall initiation date
- August 28, 2012
- Center classification date
- May 1, 2013
- Code info
- Lot 15-065-DK, Exp 1SEP2013
- More code info
- —