Reported Sep 5, 2012 · Terminated
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion,…
Bracco Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bracco Diagnostics Inc · 259 Prospect Plains Rd. · Monroe Township, NJ · 08831
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 50 mL Single Dose Vial |
| 2 | 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC |
| 3 | 0270-5264-16 |
| 4 | 0270-5264-17. |
- Lot codes and dates
Lot #: a) 9J374579J44058Exp 10/12b) 9I28973Exp 09/12
- Amount recalled
- 4,870 Vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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