Reported Sep 5, 2012 · Terminated
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco…
Bracco Diagnostics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only
- Manufactured forBracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
- Lot codes and dates
- Lot S1P272A Expiry DateDecember 2014
- Amount recalled
- 47,750 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
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
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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