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,

FDA recall notice · announced September 5, 2012 · Bracco Diagnostics

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Quantity: 4,870 Vials
Status: Terminated
Products in this recall event:
- 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 (D-1665-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.