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U.S. Department of Health and Human Services

Safety

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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.

 

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of All Lots of Ondansetron in 5% Dextrose Injection, 32 mg/50 mL Manufactured by Claris Lifesciences

 

Contact:
Aline Schimmel
312-646-6295

 

FOR IMMEDIATE RELEASE - SCHAUMBURG, IL – June 2, 2010 – Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of ondansetron injection in 5% dextrose 32mg / 50 mL (NDC number 25021-776-50) manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being recalled are: A090309, A090310, A090311 and A090312, which were distributed to hospitals, wholesalers and distributors nationwide from August 2009 through May 2010. Ondansetron injection is an intravenous product used to treat nausea and vomiting associated with chemotherapy or surgery and is supplied in a single dose plastic container.

Sagent has initiated this voluntary recall of ondansetron to the user level in conjunction with Claris Lifesciences’ recall due to the discovery of foreign material and non-sterility in one lot of ondansetron injection. Non-sterility of an antiemetic administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.SagentPharma.com. Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about ondansetron injection may contact Sagent Medical Affairs (866-625-1618 option 3).

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.

About Sagent Pharmaceuticals, Inc.

Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. Sagent has created a global network of resources yielding a portfolio of pharmaceutical products that fulfills the evolving needs of patients.

 

 

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