Status
Terminated
Drug Enforcement D-122-2013
Lack of Assurance of Sterility
Classification
Class II
Report Date
January 9, 2013
Termination Date
October 7, 2016
Product Information
- Product description
- Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
- Product quantity
- 8919 vials
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- New England Compounding Center
- Address
-
697 Waverly St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-122-2013
- Event ID
- 63305
- Recall initiation date
- September 26, 2012
- Center classification date
- December 31, 2012
- Code info
- All lot codes
- More code info
- —