Status
Terminated
Drug Enforcement D-1663-2012
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Classification
Class III
Report Date
September 5, 2012
Termination Date
July 8, 2013
Product Information
- Product description
- Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
- Product quantity
- 47,750 vials
- Reason for recall
- Short Fill: The product is being recalled due to a potential underfill of the affected vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Bracco Diagnostics Inc
- Address
-
259 Prospect Plains Rd., Building H
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1663-2012
- Event ID
- 62636
- Recall initiation date
- April 16, 2012
- Center classification date
- August 27, 2012
- Code info
- Lot S1P272A Expiry Date: December 2014
- More code info
- —