Recalls / Class II
Class IID-1665-2012
Product
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.
- Brand name
- Multihance
- Generic name
- Gadobenate Dimeglumine
- Active ingredient
- Gadobenate Dimeglumine
- Route
- Intravenous
- NDC
- 0270-5264
- FDA application
- NDA021358
- Affected lot / code info
- Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Why it was recalled
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Recalling firm
- Firm
- Bracco Diagnostics Inc
- Manufacturer
- BRACCO DIAGNOSTICS INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Rd., Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 4,870 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-16
- FDA classified
- 2012-08-28
- Posted by FDA
- 2012-09-05
- Terminated
- 2013-11-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1665-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.