D-1663-2012 Class III Terminated
FDA drug recall D-1663-2012 was initiated by Bracco Diagnostics Inc on April 16, 2012 and is designated Class III. Reason for recall: Short Fill: The product is being recalled due to a potential underfill of the affected vials. The recall status is terminated (terminated July 8, 2013). Affected quantity: 47,750 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2012
- Initiation Date
- April 16, 2012
- Termination Date
- July 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,750 vials
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
Reason for Recall
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Distribution Pattern
Nationwide
Code Information
Lot S1P272A Expiry Date: December 2014