Status
Terminated
Drug Enforcement D-1665-2012
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Classification
Class II
Report Date
September 5, 2012
Termination Date
November 13, 2013
Product Information
- Product description
- 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.
- Product quantity
- 4,870 Vials
- Reason for recall
- Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Bracco Diagnostics Inc
- Address
-
259 Prospect Plains Rd., Building H
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1665-2012
- Event ID
- 62735
- Recall initiation date
- April 16, 2012
- Center classification date
- August 28, 2012
- Code info
- Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
- More code info
- —