FDAFDA · Food and drugs·Recall number D-1665-2012
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
Published September 5, 2012 · Recall initiated: April 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MULTIHANCE
- Manufacturer
- Bracco Diagnostics Inc
- Distributor
- Nationwide
- Lot
- Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States