drugs Class II Updated 2012-09-05

Bracco Diagnostics Inc recalls Multihance Multipack (gadobenate dimeglumine) injection, 529

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
View official government recall

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