Why it was recalled
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
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.
Lot numbers, UPCs & expiration codes
Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
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-1665-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 16, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 4,870 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc
Original FDA data
Every field from FDA enforcement report D-1665-2012, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 62735
- Address
- 259 Prospect Plains Rd.
- Address (line 2)
- Building H
- Code information
- Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
- Postal code
- 08831
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1665-2012
- Classification
- Class II
- Recalling firm
- Bracco Diagnostics Inc
- Product quantity
- 4,870 Vials
- Termination date
- Nov 13, 2013
- Reason for recall
- Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 16, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2012