Why it was recalled
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Product description
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
Lot numbers, UPCs & expiration codes
Lot S1P272A Expiry Date: December 2014
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1663-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 16, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 47,750 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc
Original FDA data
Every field from FDA enforcement report D-1663-2012, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 62636
- Address
- 259 Prospect Plains Rd.
- Address (line 2)
- Building H
- Code information
- Lot S1P272A Expiry Date: December 2014
- Postal code
- 08831
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1663-2012
- Classification
- Class III
- Recalling firm
- Bracco Diagnostics Inc
- Product quantity
- 47,750 vials
- Termination date
- Jul 8, 2013
- Reason for recall
- Short Fill: The product is being recalled due to a potential underfill of the affected vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 16, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2012