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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Berlex Voluntarily Recalls Ultravist  Injection 370 mgI/mL

Contact:
Richard Salem
973-305-5260

FOR IMMEDIATE RELEASE -- Wayne, NJ -- July 31, 2006 -- Berlex, Inc., a US affiliate of Schering AG, Germany, is voluntarily recalling all lots of its X-ray contrast agent Ultravist® Injection 370 mgI/mL (iopromide injection), as part of a worldwide recall, due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of Ultravist (150 mgI/mL, 240 mgI/mL, 300 mgI/mL). Berlex is undertaking this recall in consideration of the potential for serious safety problems if the product is administered to patients, including thrombosis of blood vessels, thromboembolism, and injury or infarction of end organs such as heart, kidney, and brain.

Hospitals, imaging centers and other healthcare facilities should not use any Ultravist® Injection 370 mgI/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps in order to protect patients from any potential safety risks,” said Richard Nieman, MD, Vice President and Head of Medical Affairs for Berlex.

Berlex is undertaking this recall of Ultravist 370 mgI/mL due to the presence of particulate matter in conjunction with crystallization in consideration of the potential for thromboembolic safety problems if an affected product is administered to patients. On Thursday, July 20, 2006, Berlex voluntarily recalled a single lot of Ultravist® Injection 370 mgI/mL, 125 mL lot number 41500A (NDC 50419-346-12, EXP 01/2007) in the US due to the presence of particulate matter in conjunction with crystallization.

While Berlex and Schering AG, Germany are investigating the situation, the company is taking precautionary action by initiating this recall. Berlex has informed the FDA of its actions and maintains a close ongoing dialogue with the Agency.

As is standard practice, and per the Ultravist package insert, all parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.

Berlex will credit accounts for all returned Ultravist® Injection 370 mgI/mL product. Berlex is working with Capital Returns, Inc. to facilitate the return process. Those with questions about the return process, please call 1-800-950-5479, menu option 1.

Healthcare providers, imaging centers, wholesalers or patients with other questions may contact the company at 1-866-BERLEX-5 or 1-866-237-5395.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

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