FDA recall D-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.

Reason for recall

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-04-16

Report date

2012-09-05

Termination date

2013-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1665-2012