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July 20, 2006 — /FDA News/ — Wayne, N.J. — Berlex, Inc. has initiated a nationwide recall of a single lot (No. 41500A) of its intravenous X-ray contrast agent, Ultravist(r) Injection 370 mgI/mL, 125 mL, (iopromide injection) NDC 50419-246-12, EXP 01/2007, due to the presence of particulate matter in conjunction with crystallization. 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 of the affected lot number 41500A of Ultravist Injection 370mgI/mL, 125 mL for patient care and should immediately quarantine any product for return. Berlex is working closely with the FDA to communicate and coordinate this recall.
Berlex, Inc. is voluntarily recalling this lot after an investigation of two customer complaints of vials that exhibited crystallization. Berlex, Inc. immediately placed remaining inventory of Ultravist 370 mgI/125 mL, lot number 41500A on hold to prevent further distribution of product from this lot. The investigation is ongoing regarding this matter to determine whether any other lots of this product might be affected.
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 products from lot number 41500A and shipping costs. Berlex is working with Capital Returns, Inc. to facilitate the return process.
Healthcare providers, imaging centers, wholesalers or patients with 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 [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500 [which may be downloaded from the FDA website at www.fda.gov/MedWatch/getforms.htm] by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].