Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not f...

FDA Drug Recall #D-1665-2012 — Class II — April 16, 2012

Recall Summary

Recall Number D-1665-2012
Classification Class II — Moderate risk
Date Initiated April 16, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bracco Diagnostics Inc
Location Monroe Township, NJ
Product Type Drugs
Quantity 4,870 Vials

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.

Reason for Recall

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12

Other Recalls from Bracco Diagnostics Inc

Recall # Classification Product Date
D-1083-2014 Class III VoLumen Barium Sulfate Suspension (0.1 % w/v, 0... Dec 16, 2013
D-914-2013 Class III Tagitol V Barium Sulfate Suspension (40% w/v, 3... Jul 19, 2013
D-885-2013 Class II Gastrografin (Diatrizoate Meglumine and Diatriz... Jun 21, 2013
D-1684-2012 Class II CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 mi... Jun 1, 2012
D-1663-2012 Class III Bracco Diagnostics multihance (gadobenate dimeg... Apr 16, 2012

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.